Health Fraud Product Database

Health Fraud Product Database | FDA
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For Consumers
Health Fraud Scams
Health Fraud Product Database
Health Fraud Scams
In this section
This list includes unapproved products that have been subject to FDA health fraud* related violations. These products have been cited in
warning letters
online advisory letters
recalls
public notifications
, and
press announcements
for issues varying from products marketed as dietary supplements claiming to cure, mitigate, treat or prevent disease, to the use of undeclared ingredients or new dietary ingredients.
This list only includes a small fraction of the potentially hazardous products marketed to consumers online and in retail establishments. Even if a product is not included in this list, consumers should exercise caution before using certain products.
For more information, see the
Medication Health Fraud
and
Health Fraud Scams
webpages.
Search Database
(Table results update automatically as you type)
Date
Product
Firm
Firm Address
Source/URL(s)
Subject
Action
Program Area(s)
Additional Outcome
04/07/2026
Yeicob Ácido Hialurónico
n/a
n/a
raysvitamins.com
Undeclared dexamethasone phosphate and diclofenac
Public Notification
Drugs
04/07/2026
KUKA FLEX CBD
n/a
n/a
ebay.com
Undeclared diclofenac
Public Notification
Drugs
04/07/2026
DINA Acido Hialurónico
n/a
n/a
ebay.com
Undeclared dexamethasone, methocarbamol, meloxicam and phenolphthalein
Public Notification
Drugs
04/07/2026
RM Joe
n/a
n/a
naturistamexicanstore.com
Undeclared dexamethasone phosphate and diclofenac
Public Notification
Drugs
04/07/2026
Curcuflex
n/a
n/a
ebay.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
04/07/2026
Umary
Various
Various
solovital.com; Main Products, Inc.; ebay.com; ibeautistore.com
Undeclared diclofenac, dexamethasone and omeprazole
Public Notification
Drugs
Recall
Additional Recall
Warning Letter
Drug Alert
04/06/2026
WAP Sensual Enhancement
n/a
n/a
ebay.com
Undeclared sildenafil, tadalafil and flibanserin
Public Notification
Drugs
04/03/2026
Addall XR Shot
ZMB Enterprises, LLC
Carlsbad, CA
n/a
Contains 2-amino-6-methylheptane (DMHA) and undeclared 1,4-DMAA
Alert
04/03/2026
om
ZMB Enterprises, LLC
Carlsbad, CA
n/a
Contains Phenibut (β-phenyl-GABA) and undeclared 1,4-DMAA (1,4-dimethylamylamine)
Alert
03/26/2026
Gold Lion Aphrodisiac Chocolate Sachet
Gear Isle
West Sacramento, CA
Gear Isle
Undeclared sildenafil and tadalafil
Recall
Foods, Drugs
03/14/2026
Boner Bear Honey
Pure Vitamins and Natural Supplements, LLC
Tampa, FL
n/a
Undeclared sildenafil and tadalafil
Recall
Drugs
Public Notification
03/14/2026
Red Bull Extreme
Pure Vitamins and Natural Supplements, LLC
Tampa, FL
n/a
Undeclared sildenafil
Recall
Drugs
Public Notification
03/14/2026
Blue Bull Extreme
Pure Vitamins and Natural Supplements, LLC
Tampa, FL
n/a
Undeclared sildenafil
Recall
Drugs
Public Notification
03/13/2026
Kian Pee Wan
Aphreseller
Flushing, NY
ebay.com; buy-herbal.com
Undeclared dexamethasone and cyproheptadine
Public Notification
Drugs
Recall
03/11/2026
Chupa Panza
Naturista Reyes (Suerte Y Salud LLC, La Tia Mana LLC)
N/A
ebay.com
Undeclared yellow oleander
Alert
Foods
02/26/2026
ULTRA ADVANC3 GOLD
n/a
n/a
naturistarex.com
Undeclared dexamethasone, diclofenac and methocarbamol
Public Notification
Drugs
02/26/2026
ULTRA ADVANC3
n/a
n/a
amazon.com
Undeclared dexamethasone, diclofenac and methocarbamol
Public Notification
Drugs
03/03/2026
Artri Ajo Rey
n/a
n/a
naturistarex.com
Undeclared dexamethasone, diclofenac and methocarbamol
Public Notification
Drugs
02/17/2026
Advanced Alkaloids
Shaman Botanicals, LLC
1501 Iron Street North Kansas City, MO 64116
cbdamericanshaman.com
Product contains 7-Hydroxymitragynine (7-OH) in an amount more than the declared value of 7.5 mg/tablet
Recall
Foods
02/13/2026
Green Lumber (update)
Green Lumber Holdings LLC
ar isle
getgreenlumber.com, greenlumber.com
Undeclared tadalafil
Public Notification
Drugs
Recall
Recall
02/13/2026
LOVION Chocolate with Ginseng for Men
n/a
n/a
lovionusa.com
Undeclared sildenafil and tadalafil
Public Notification
Foods, Drugs
02/13/2026
Fantasy Aphrodisiac Chocolate
n/a
n/a
gearisle.com
Undeclared sildenafil
Public Notification
Foods, Drugs
02/13/2026
DTF Sexual Chocolate
Nalpac
Ferndale, MI
shopsexology.com
Undeclared sildenafil and tadalafil
Public Notification
Foods, Drugs
Recall
02/13/2026
Boner Bears Chocolate Syrup
Lockout Supplements
McKinney, TX
lockoutsupplements.com
Undeclared sildenafil
Public Notification
Foods, Drugs
Recall
02/13/2026
Boner Bears Chocolate Bar
n/a
n/a
elyxr.com
Undeclared sildenafil
Public Notification
Foods, Drugs
02/11/2026
Pink Pussycat Aphrodisiac Chocolate
n/a
n/a
loverslane.com
Undeclared tadalafil
Public Notification
Foods, Drugs
02/11/2026
Rhino Choco VIP
USA LESS Co.
Brooklyn, NY
usaless.com
Undeclared tadalafil
Public Notification
Foods, Drugs
Recall
02/11/2026
ilum Male Sexual Enhancement Chocolate
Gear Isle
West Sacramento, CA
ebay.com; Gear Isle
Undeclared sildenafil and tadalafil
Public Notification
Foods, Drugs
Recall
02/03/2026
Ashfiat Alharamain
Akkarco LLC
Lorton, VA
akkarco.com; amazon.com
Undeclared tadalafil
Recall
Foods
01/20/2026
GELLEN TIME TO SHINE Nail Removal Kit
n/a
n/a
amazon.com
Contains methylene chloride
Alert
Cosmetics
01/20/2026
MOROVAN GEL NAIL POLISH REMOVER
Morovan
n/a
amazon.com
Contains methylene chloride
Alert
Cosmetics
Recall
01/20/2026
EELHOE MAGIC REMOVER
n/a
n/a
walmart.com
Contains methylene chloride
Alert
Cosmetics
01/20/2026
Candy Lover GEL POLISH REMOVER
n/a
n/a
walmart.com
Contains methylene chloride
Alert
Cosmetics
01/20/2026
BORN PRETTY MAGIC GEL REMOVER
n/a
n/a
amazon.com
Contains methylene chloride
Alert
Cosmetics
01/20/2026
NIFEISHI Nail Polish GEL REMOVER
n/a
n/a
amazon.com
Contains methylene chloride
Alert
Cosmetics
01/09/2026
Modern Warrior Ready
Modern Warrior
Phoenix, AZ
n/a
Undeclared tianeptine, 1,4-DMAA, and aniracetam.
Recall
Drugs, Foods
12/02/2025
GE Labs Ykarine
GE Labs LLC
8020 Excelsior Dr, Madison, WI 53717
monsterking.eu
Undeclared trendione (estra-4,9,11-triene-3,17-dione)
Alert
Drugs
11/21/2025
mR.7 SUPER 700000
StuffbyNainax LLC
Huntsville, TX
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
Recall
11/17/2025
“Dr. Patels Measles Tablets"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Mans-Pachak Vati”
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Adel-54 Heart Care Drops"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Ayuvardhak Sutta Yog"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Parkikyor Tablets"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Ayuvardhak Sutta Yog"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Tri-Origin Ayurveda Diabetic Tablets"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Ayuvision Herbal Eye Drop"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Adel-17 Eye Care Drops"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
“Haslab Mamira Eye Drops"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Unapproved new drugs
Warning Letter
Drugs
11/17/2025
"Rheumacare Capsules"
Handelnine Global, LLC dba Navafresh
4300 S. Clinton Ave. South Plainfield, NJ 07080
navafresh.com
Presence of lead, unsafe levels of lead contamination
Warning Letter
Drugs
Alert
11/13/2025
“Ganoderma Huo Luo Dan”
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Unapproved new drugs
Warning Letter
Drugs
11/13/2025
“Hong Kong Vail Bon Tong”
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Unapproved new drugs
Warning Letter
Drugs
11/13/2025
“SAM NHUNG BO THAN”
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Unapproved new drugs
Warning Letter
Drugs
11/13/2025
“TDCARE”
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Unapproved new drugs
Warning Letter
Drugs
11/13/2025
“Vall Boon Antacid”
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Unapproved new drugs
Warning Letter
Drugs
11/03/2025
SiluetaYa Mexican Tejocote Roots
SiluetaYa, LLC
320 Gold Ave Sw Ste 620, Albuquerque NM US
siluetayausa.com
Undeclared yellow oleander
Recall
Foods
11/03/2025
SdB ELITE
OBC Group Corp
n/a
naturalvida.com
Undeclared yellow oleander
Alert
Foods
11/03/2025
SdB Semilla de Brasil Tejocote Root
OBC Group Corp
n/a
ebay.com
Undeclared yellow oleander
Alert
Foods
10/27/2025
“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches”
IBSPOT.com Inc.
1414 Willow Avenue Elkins Park, PA 19027
ibspot.com
Unapproved new drugs
Warning Letter
Drugs
10/27/2025
“Navabelle Motion Sickness Patches”
IBSPOT.com Inc.
1414 Willow Avenue Elkins Park, PA 19027
ibspot.com
Unapproved new drugs
Warning Letter
Drugs
10/23/2025
SPARTAN
n/a
n/a
vroxusa.com
Undeclared sildenafil
Public Notification
Drugs
10/23/2025
vROX
n/a
n/a
vroxusa.com
Undeclared sidenafil
Public Notification
Drugs
10/17/2025
Black Thai Honey
n/a
n/a
honeypack.com
Undeclared sildenafil, tadafil, and diclofenac
Public Notiication
Drugs
10/17/2025
Ashfiat Alharamain Energy Support
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
10/06/2025
Osteo Sin Max
n/a
n/a
ebay.com
Undeclared dexamethasone, methocarbamol, and phenylbutazone
Public Notification
Drugs
10/06/2025
Mojo Max Fusion XXX
n/a
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
10/03/2025
Contra Reumas
n/a
n/a
naturistarex.com
Undeclared dexamethasone, diclofenac, and methocarbamol
Public Notification
Drugs
09/30/2025
Me Vale Madre
n/a
n/a
ebay.com
Undeclared acetaminophen and diclofenac
Public Notification
Drugs
09/23/2025
Agebox iKids Growth Day Formula
n/a
n/a
agebox.com
Undeclared ibutamoren
Public Notification
Drugs
09/23/2025
Agebox iKids Growth Night Formula
n/a
n/a
agebox.com
Undeclared ibutamoren
Public Notification
Drugs
09/23/2025
Flexi Bion
n/a
n/a
ebay.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
09/23/2025
SILINTAN
123Herbals
7214 Berne St Rosemead, CA 91770
123herbals.com
Undeclared meloxicam
Public Notification
Drugs
Warning Letter
Recall
09/18/2025
Primal Herbs Volume
Primal Supplements Group LLC
Albuquerque, NM
primalherbs.com
Undeclared sildenafil
Public Notification
Drugs
Recall
09/16/2025
“StellaLife VEGA Oral Care Recovery Kit”
Stellalife, Inc.
P.O. Box 1204 Northbrook, IL 60065
stellalife.com
Unapproved new drugs
Warning Letter
Drugs
09/16/2025
“StellaLife VEGA Oral Care Peppermint Gel"
Stellalife, Inc.
P.O. Box 1204 Northbrook, IL 60065
stellalife.com
Unapproved new drugs
Warning Letter
Drugs
09/16/2025
“StellaLife VEGA Oral Care Spearmint Rinse”
Stellalife, Inc.
P.O. Box 1204 Northbrook, IL 60065
stellalife.com
Unapproved new drugs
Warning Letter
Drugs
09/16/2025
“StellaLife VEGA Oral Care Peppermint Rinse”
Stellalife, Inc.
P.O. Box 1204 Northbrook, IL 60065
stellalife.com
Unapproved new drugs
Warning Letter
Drugs
09/16/2025
“StellaLife VEGA Oral Care Coconut Rinse”
Stellalife, Inc.
P.O. Box 1204 Northbrook, IL 60065
stellalife.com
Unapproved new drugs
Warning Letter
Drugs
09/08/2025
“Tianeptine Ethyl Ester Sulfate”
PureRawz
1404 Lakeshire Dr. Knoxville, TN 37922
purerawz.co
Unapproved new drugs
Warning Letter
Drugs
09/08/2025
“Tianeptine Free-Acid"
PureRawz
1404 Lakeshire Dr. Knoxville, TN 37922
purerawz.co
Unapproved new drugs
Warning Letter
Drugs
09/08/2025
“Tianeptine Sodium”
PureRawz
1404 Lakeshire Dr. Knoxville, TN 37922
purerawz.co
Unapproved new drugs
Warning Letter
Drugs
09/08/2025
“Tianeptine Sulfate"
PureRawz
1404 Lakeshire Dr. Knoxville, TN 37922
purerawz.co
Unapproved new drugs
Warning Letter
Drugs
09/08/2025
"Tianeptine Ultimate”
PureRawz
1404 Lakeshire Dr. Knoxville, TN 37922
purerawz.co
Unapproved new drugs
Warning Letter
Drugs
09/05/2025
FTX PLUS
n/a
n/a
walmart.com
Undeclared dexamethasone phosphate and diclofenac
Public Notification
Drugs
09/05/2025
REUMA KING
n/a
n/a
etsy.com
Undeclared dexamethasone, diclofenac, and methocarbamol
Public Notification
Drugs
08/25/2025
Green Vitality dba Gr33n
Green Vitality dba Gr33n
1630 Peachtree Industrial Blvd Suwanee, GA 30024
gr33n.com
Unapproved new drug
Warning Letter
Drugs
08/25/2025
“Similasan Allergy Eye Relief” (all variations)
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Complete Eye Relief"
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Computer Eye Relief”
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Pink Eye Relief"
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Redness & Itchy Eye Relief"
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Stye Eye Relief”
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Similasan Aging Eye Relief"
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Boiron Optique 1 Eye Irritation Relief”
Supply Center USA
30 N Gould St Ste R Sheridan, WY 82801
supplycenterusa.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Jimerito (Melipona) Honey”
Mel Honey US
152 Wapiti Loop Hyrum, UT 84319-2012
melhoney.us/
Unapproved new drug
Warning Letter
Drugs
08/25/2025
“Cineraria Maritima Eye Drops”
Homeopathic Educational Services dba Homeopathic Family Medicine
812 Camelia Street, Suite C Berkeley, CA 94710-1418
homeopathic.com
Unapproved new drug
Warning Letter
Drugs
08/25/2025
“Holistic Honey EYE DROP” (also referred to on your website as “Jimerito Honey Eye Drops”)
My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD
2452 Gillingham Circle Thousand Oaks, CA 91362
myholistichoney.com
Unapproved new drug
Warning Letter
Drugs
08/25/2025
“Trew Vision CBD Eye Drops"
Trew Balance
11200 W. Michigan Ave. Suite #3 Youngtown, AZ 85363
trewbalance.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Amazing Colyrio"
Life Enthusiast Co-op
711 S Carson Street Suite 4 Carson City, NV 89701
life-enthusiast.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“Fulvic Eyes"
Life Enthusiast Co-op
711 S Carson Street Suite 4 Carson City, NV 89701
life-enthusiast.com
Unapproved new drugs
Warning Letter
Drugs
08/25/2025
“MSM Gold Drops”
Life Enthusiast Co-op
711 S Carson Street Suite 4 Carson City, NV 89701
life-enthusiast.com
Unapproved new drugs
Warning Letter
Drugs
08/22/2025
PAIN FLEX
NaTerra
Heriberto Jara 1817, Col. Jardines Alcalde, Guadalajara, Jalisco, MX 44290
amazon.com
Undeclared dexamethasone and methocarbamol
Public Notification
Drugs
07/22/2025
FATZorb
Beauty Collection International Pte Ltd
90 Hougang Avenue 10, #03-08 HougangMall Singapore, 538766 SG
ebay.com
Undeclared sibutramine, desmethyl sibutramine, benzyl sibutramine, and phenolphthalein
Public Notification
Drugs
07/16/2025
STNR Delta-8 and Delta-9 Gummies in various flavors
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810
stnrcreations.com
Adulterated human foods
Warning Letter
Foods
07/16/2025
STNR Delta-8 and Delta-9 Candy Clusters Nana Berry Gummies
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810
stnrcreations.com
Adulterated human foods
Warning Letter
Foods
07/16/2025
STNR Delta-8 Gummies in various flavors
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810
stnrcreations.com
Adulterated human foods
Warning Letter
Foods
07/16/2025
STNR Delta-8 and Delta-9 Cookies in various flavors
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810
stnrcreations.com
Adulterated human foods
Warning Letter
Foods
07/16/2025
STNR Delta-8 and Delta-9 Brownies
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600 Orlando, FL 32810
stnrcreations.com
Adulterated human foods
Warning Letter
Foods
07/08/2025
Versace Real Honey for Men
Sekerciler Tic. ve San. Ltd. Sti.
2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TR
Various websites
Undeclared sildenafil, tadalafil, and acetaminophen
Public Notification
Drugs
07/08/2025
Black Horse Miracle Honey for Men
Sekerciler Tic. ve San. Ltd. Sti.
2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TR
Various websites
Undeclared sildenafil and tadalafil
Public Notification
Drugs
07/08/2025
Secret Miracle Honey Extra Strength
Sekerciler Tic. ve San. Ltd. Sti.
2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TR
Various websites
Undeclared sildenafil, tadalafil, and acetaminophen
Public Notification
Drugs
07/08/2025
Black Panther Miracle Honey for Men
Sekerciler Tic. ve San. Ltd. Sti.
2.Organize Sanayi Bolgesi2.Cadde No:11Yesilyurt, Malatya TR
Various websites
Undeclared sildenafil, tadalafil, and acetaminophen
Public Notification
Drugs
06/24/2025
Toki Slimming Candy
Hoang Huy Investment & Trading Co., Ltd.
84 Street 23, Giao Luu City Urban Area, Co Nhue 2 Ward, Bac Tu Liem District, Hanoi, Vietnam
ebay.com
Undeclared sibutramine
Public Notification
Foods
05/15/2025
Dolotrex
Innovacion Natural
10910 Long Beach Blvd., Suite 103-402, Lynnwood, CA 90262
innvocaionnatural.com
Undeclared diclofenac
Public Notification
Drugs
05/15/2025
Umovy
EREN NATURALS SA DE CV
Calle Tepame Paraisos De 1518Col. Paraisos Del Colli, ZapopanZapopan, Jalisco MX
umovy-usa.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
Recall
05/15/2025
Unavy
EREN NATURALS SA DE CV
Calle Tepame Paraisos De 1518Col. Paraisos Del Colli, ZapopanZapopan, Jalisco MX
umary-usa.com
Undeclared dexamethasone, diclofenac, and omeprazole
Public Notification
Drugs
Recall
05/06/2025
Endurance Boost
EnShiShiXiangNiShangMaoYouXianGongSi
150-67 Northern Blvd. Flushing, NY 11354
amazon.com
Undeclared propoxyphenylsildenafil and sildenafil
Recall
Drugs
04/25/2025
Male Ultra Pro
Health Fixer
Tempe, AZ 85288
amazon.com
Undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil
Recall
Drugs
04/25/2025
Ultra Armor
Health Fixer
Tempe, AZ 85288
amazon.com
Undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil
Recall
Drugs
04/25/2025
Electro Buzz
Health Fixer
Tempe, AZ 85288
amazon.com
Undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil
Recall
Drugs
04/25/2025
Malextra
Health Fixer
Tempe, AZ 85288
amazon.com
Undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil
Recall
Drugs
04/25/2025
Male Ultra
Health Fixer
Tempe, AZ 85288
amazon.com
Undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil
Recall
Drugs
04/25/2025
Artrifan King
Omega Nutrition
Jorge Washington No 108, Col. Las Americas, Hidalgo Del Parral, Chihuahua, MX, 33880
artriking.us
Undeclared dexamethasone, diclofenac, and methocarbamol
Public Notification
Drugs
04/23/2025
Pain Flex Forte
NaTerra
Heriberto Jara 1817, Col. Jardines Alcalde, Guadalajara, Jalisco, MX 44290
ibspot.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
02/28/2025
AL'IVER® Nail Polish Quick Gel Remover
n/a
China
amazon.com
Contains methylene chloride
Alert
Cosmetics
02/28/2025
AL’IVER® Professional MAGIC REMOVER
n/a
China
amazon.com
Contains methylene chloride
Alert
Cosmetics
02/28/2025
AIBRIT Gel Nail Polish Remover
n/a
China
amazon.com
Contains methylene chloride
Alert
Cosmetics
02/28/2025
BesTby Gel Nail Polish Remover
n/a
China
amazon.com
Contains methylene chloride
Alert
Cosmetics
02/10/2025
ADVANCE KING
n/a
n/a
naturistastore.com
Undeclared dexamethasone, diclofenac, and methocarbamol
Public Notification
Drugs
02/10/2025
bio LIT
n/a
n/a
Various websites
Undeclared 1,4-dimethylamylamine (DMAA)
Public Notification
Foods
02/10/2025
Special Edition Platinum 10K
n/a
n/a
Various websites
Undeclared acetaminophen, tadalafil and vardenafil
Public Notification
Drugs
02/10/2025
vROX
n/a
n/a
Various websites
Undeclared sildenafil
Public Notification
Drugs
02/10/2025
HimGo
n/a
n/a
ebay.com
Undeclared sildenafil
Public Notification
Drugs
02/10/2025
VITALITY
One Source Nutrition
Benton, AR
zen-herbs.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
Recall
12/27/2024
Natural MiracleZEN Platinum 70000
n/a
n/a
Various websites
Undeclared tadalafil and sildenafil
Public Notification
Drugs
12/27/2024
RIGIDRX
n/a
n/a
Various websites
Undeclared tadalafil
Public Notification
Drugs
12/27/2024
The Goat
n/a
n/a
Various websites
Undeclared sildenafil
Public Notification
Drugs
12/27/2024
X3 500L GOLD EDITION
n/a
n/a
Various websites
Undeclared tadalafil and sildenafil
Public Notification
Drugs
12/26/2024
Rhino 69 Gummy
n/a
n/a
Various websites
Undeclared tadalafil
Public Notification
Drugs
12/26/2024
Lucky Guy Platinum 18000
n/a
n/a
Various websites
Undeclared tadalafil
Public Notification
Drugs
12/26/2024
Rhino 11 Gummy
n/a
n/a
Various websites
Undeclared tadalafil
Public Notification
Drugs
12/26/2024
Rhino Gummy Royal 50000
n/a
n/a
Various websites
Undeclared tadalafil
Public Notification
Drugs
12/19/2024
WILDMAN
n/a
n/a
loveproducts.net
Undeclared sildenafil, tadalafil, sibutramine, desmethyl sibutramine and phenolphthalein
Public Notification
Drugs
12/13/2024
VidaSlim 90-day (Original Root, Root Plus, and Root Capsules)
Motivate Me Ashley, LLC
San Antonio, TX
Vidaslim Co./Vidaslim USA
Contains undeclared yellow oleander
Alert
Foods
Recall
12/13/2024
VidaSlim 30-day (Original Root, Root Plus, and Root Capsules)
Motivate Me Ashley, LLC
San Antonio, TX
Vidaslim Co./Vidaslim USA
Contains undeclared yellow oleander
Alert
Foods
Recall
12/13/2024
VidaSlim 7-day Sample Size (Original Root, Root Plus, and Root Capsules)
Motivate Me Ashley, LLC
San Antonio, TX
Vidaslim Co./Vidaslim USA
Contains undeclared yellow oleander
Alert
Foods
Recall
12/13/2024
VidaSlim Hot Body Brew (Strawberry and Peach flavors)
Motivate Me Ashley, LLC
San Antonio, TX
Vidaslim Co./Vidaslim USA
Contains undeclared yellow oleander
Alert
Foods
Recall
12/10/2024
Fouzee Sugarlin Herbal Formula capsules
Shoppers-Plaza
Los Angeles, CA
shoppers-plaza.com
Undeclared metformin and glyburide
Public Notification
Drugs
Recall
12/03/2024
New Me
n/a
n/a
Shopnewmeroot.com
Contains undeclared yellow oleander
Alert
Foods
11/27/2024
LipoFit Turbo
n/a
n/a
n/a
Undeclared sibutramine, metformin, fluoxetine, and furosemide
Public Notification
Drugs
11/22/2024
THERMO SHOCK
n/a
n/a
scilabsnutrition.com
Undeclared 1,3-dimethylamylamine (1,3-DMAA)
Public Notification
Foods
11/22/2024
Force Forever
GNMART INC
Dover Plains, NY
gnmart.com
Undeclared diclofenac and dexamethasone
Public Notification
Drugs
Recall
11/19/2024
HON-E-LING
n/a
n/a
Examination of imported goods
Undeclared sibutramine and sildenafil
Public Notification
Drugs
11/19/2024
Umary
MXBBB
n/a
amazon.com
Undeclared diclofenac and omeprazole
Recall
Drugs
11/08/2024
VITAFER-L Gold 10ml
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
11/08/2024
VITAFER-L Gold 20ml
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
11/08/2024
VITAFER-L Gold 500ml
Natural Dior LLC
n/a
amazon.com; www.walmart.com
Undeclared tadalafil
Public Notification
Drugs
Recall
11/06/2024
PeakMax Capsules
VitalityVita
Sacramento, CA
vitalityvita.com
Undeclared sildenafil and diclofenac
Recall
Drugs
Public Notification
11/06/2024
VitalityXtra Capsules
VitalityVita
Sacramento, CA
vitalityvita.com
Undeclared sildenafil
Recall
Drugs
Public Notification
11/04/2024
ZapMax Capsules
Boulla LLC
Sacramento, CA
amazon.com
Undeclared sildenafil and diclofenac
Recall
Drugs
Public Notification
11/04/2024
ZoomMax Capsules
Boulla LLC
Sacramento, CA
amazon.com
Undeclared sildenafil and diclofenac
Recall
Drugs
Public Notification
11/01/2024
Nhan Sam Tuyet Lien Truy Phong Hoan
n/a
Flushing, NY
buy-herbal.com
Undeclared chlorpheniramine, dexamethasone and furosemide
Public Notification
Drugs
Recall
10/30/2024
ITCHA XS
n/a
n/a
Examination of international mail shipments
Undeclared fluoxetine or bupropion
Public Notification
Drugs
10/30/2024
OneMultivitaminic GAF-Plus Advance
n/a
n/a
lipoblueadvance.com
Undeclared dexamethasone, acetaminophen, and aspartame
Public Notification
Drugs
10/30/2024
Skin-Cap aerosol spray products
Chemigroup France, formerly known as Cheminova Laboratories
n/a
skincap.com; amazon.com; walmart.com
Undeclared high-potency glucocorticosteroid
Drug Alert
Drugs
10/07/2024
Trinity Gold
n/a
n/a
trinitygoldnutrition.com
Undeclared acetaminophen, diclofenac and phenylbutazone
Public Notification
Drugs
10/02/2024
Body Shape Weight Loss System
n/a
n/a
Examination of international mail shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
09/26/2024
Ácido Hialurónico
n/a
n/a
ebay.com
Undeclared diclofenac
Public Notification
Drugs
09/11/2024
AK Forte
C&A Naturistics
National City, CA
productosnaturalesca.com, ebay.com, etsy.com
Undeclared acetaminophen and diclofenac
Public Notification
Drugs
Warning Letter
Recall
09/05/2024
Amazy
n/a
n/a
various websites, including SoloVital, Main Products and Amazon, and in some retail stores
Undeclared diclofenac and omeprazole
Drug Alert
Drugs
Public Notification
08/21/2024
Boom Max
Boulla LLC
Sacramento, CA
amazon.com
Undeclared sildenafil and acetaminophen
Recall
Drugs
07/30/2024
RMSOL GRACIAN
n/a
n/a
botanical-be.com
Undeclared diclofenac
Public Notification
Drugs
07/30/2024
SILI PHARMA
n/a
n/a
botanical-be.com
Undeclared diclofenac
Public Notification
Drugs
07/26/2024
Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom
n/a
n/a
n/a
Product label indicates the presence of kratom alkaloids, mitragynine and 7-hydroxymitragynine (7-OH mitragynine)
Safety Alert
Foods
07/10/2024
Vail-Bon Jie Yang Wan
123herbals
Rosemead, CA
everymarket.com
Undeclared dexamethasone and chlorpheniramine
Public Notification
Drugs
Warning Letter
Recall
07/10/2024
Gold Hard Steel Plus
Supercore Products Group
Atlanta, GA
hardsteelusa.com
Undeclared sildenafil
Public Notification
Drugs
Recall
07/05/2024
Hard Steel
Supercore Products Group
Atlanta, GA
hardsteelusa.com
Undeclared sildenafil and acetaminophen
Public Notification
Drugs
Recall
06/28/2024
Diamond Shruumz
Prophet Premium Blends
Santa Ana, CA
diamondshruumz.com
Products contain Muscimol
Recall
Foods
Investigation of Illnesses
06/20/2024
Infla-650
Guru Inc.
Lilburn, GA
nutraherbusa.com; nutra650.com
Undeclared acetaminophen, diclofenac and phenylbutazone
Public Notification
Drugs
Recall
06/14/2024
La Paix
n/a
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
04/17/2024
Ossos-Sans
n/a
n/a
Undeclared diclofenac and methocarbamol
Public Notification
Drugs
Warning Letter
04/05/2024
Eva Nutrition Mexican Tejocote root
Global Mix, Inc.
New York
etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com
Public Notification
Recall
Foods
04/05/2024
Science of Alpha Mexican Tejocote root
Global Mix, Inc.
New York
etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com
Contains undeclared yellow oleander
Recall
Foods
04/05/2024
NWL Nutra Mexican Tejocote root
Global Mix, Inc.
New York
etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com
Contains undeclared yellow oleander
Recall
Foods
04/05/2024
Niwali Mexican Tejocote root
Global Mix, Inc.
New York
etsy.com; amazon.com; eva-nutrition.com; tejocotemexican.com; niwali.com; scienceofalpha.com
Contains undeclared yellow oleander
Recall
Foods
04/04/2024
Elv Control Herbal Supplement
World Green Nutrition, Inc.
n/a
n/a
Contains undeclared yellow oleander
Recall
Foods
02/29/2024
SNAKE BONES Anti-Rheumatic Capsules
n/a
n/a
n/a
Undeclared piroxicam
Public Notification
Drugs
02/29/2024
QUICK Rheumatism Capsule, Tiger Wang Biaod
n/a
n/a
n/a
Undeclared piroxicam
Public Notification
Drugs
01/30/2024
Arize
Today the World
n/a
getarize.com
Undeclared nortadalafil
Public Notification
Drugs
Recall
01/30/2024
Schwinng
Today the World; STOP CLOPEZ CORP
n/a
schwinnng.com; amazon.com
Undeclared nortadalafil
Public Notification
Drugs
Recall
Additional Recall
01/30/2024
Sustain®
Today the World
n/a
sustainformula.com; amazon.com
Undeclared tadalafil and avanafil
Public Notification
Drugs
Recall
01/26/2024
nwl NUTRA Mexican Tejocote Root
n/a
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
EVA NUTRITION Mexican Tejocote Root
Global Mix Inc.
n/a
eva-nutrition.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ELV King All Natural Tejocote Root
Sunset Sales +
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ELV King Tejocote Root Raiz de Tejocote
Sunset Sales +
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ALIPOTEC Tejocote Root Dietary Supplement Pieces
ALIPOTEC RAIZ DE TEJOCOTE
n/a
alipotectejocote.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Science of ALPHA Mexican Tejocote Root
Natural Supplements, LLC
n/a
tejocotemexican.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
H & Natural Tejo Root Raiz de Tejocote
H and Natural
n/a
handnatural.com
Contains undeclared yellow oleander
Alert
Foods
Recall
01/26/2024
H & Natural Brazil Seed
H and Natural
n/a
handnatural.com
Contains undeclared yellow oleander
Alert
Foods
Recall
01/26/2024
ALIPOTEC Tejocote Root Raiz de Tejocote
Backstage CTC Seller
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
Recall
01/26/2024
ALIPOTEC Tejocote Root Dietary Supplement Pieces
n/a
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Nutraholics ELV Tejocote Root Dietary Supplement Pieces
n/a
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces
n/a
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ALIPOTEC Tejocote Root
n/a
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Niwali Raiz de Tejocote
Global Mix, Inc.
n/a
etsy.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Science of Alpha Mexican Tejocote Root
Global Mix, Inc.
n/a
etsy.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ALIPOTEC Tejocote Root Dietary Supplement Pieces
Innovacion Natural, LLC
n/a
innovacionnatural.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
Tejocotex Tejocote Root
Pastor-Villareal, Inc.
n/a
amazon.com
Contains undeclared yellow oleander
Alert
Foods
01/26/2024
ALIPOTEC ELV Mexican Tejocote Root
Alipotec South TX; World Green Nutrition, Inc.
n/a
alipotecus.com
Contains undeclared yellow oleander
Alert
Foods
01/12/2024
ELV Alipotec Mexican Tejocote Root Supplement Pieces
World Green Nutrition, Inc.
n/a
n/a
Contains undeclared yellow oleander
Recall
Foods
01/02/2024
ENDUREA
n/a
n/a
amazon.com
Undeclared tadalafil and sildenafil
Public Notification
Drugs
01/02/2024
ForeverMen
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
Recall
01/02/2024
Seraphim Z
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
01/05/2024
Blue Boy Herb Co. products, including Arthritis Formula, Blood Tonic, Diabecon, Brain Tonic, Gout Formula, Gravel Formula, Heart Tonic, Liver Tonic, Lung Tonic, Oats +, Poke Root Formula, Poke Root Salve, Pressex, Rumalaya, Sacred Meditation Oil, Turmeric Tincture, and Uterine
Blue Boy Herb Company
10060 Road 263Carriere, MS 39426
New Drug
Online Advisory Letter
Foods; Drugs
12/26/2023
Wild Bull
n/a
n/a
amazon.com
Undeclared nortadalafil
Public Notification
Drugs
12/26/2023
TO THE MOON
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
Recall
12/26/2023
T XTRA Strength Test Booster
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
12/26/2023
Ram It
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
Recall
12/21/2023
Govvi WOW!
n/a
n/a
ebay.com
Undeclared 1,4-dimethylamylamine (DMAA)
Public Notification
Foods
11/29/2023
Magnum XXL 9980
Meta Herbal
E. Hampton, NY
amazon.com
Undeclared sildenafil
Recall
Drugs
11/21/2023
Neptune's Fix
n/a
n/a
n/a
Contains tianeptine
Alert
Drugs
11/17/2023
Himalayan Pain Relief Tea
WS Global, Inc
Brooklyn, NY
himalayan-painrelieftea.com
Undeclared diclofenac and dexamethasone
Public Notification
Drugs
Recall
11/17/2023
Tepee Herbal Tea
n/a
n/a
amazon.com
Undeclared piroxicam
Public Notification
Drugs
11/17/2023
Notoginseng Formula Special Gout Granule
n/a
n/a
ebay.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
11/03/2023
Dr. Ergin's SugarMD Advanced Glucose Support
n/a
n/a
sugarmds.com
Undeclared Glyburide and Metformin
Public Notification
Drugs
Recall
10/19/2023
The Rock
Noah’s Wholesale, LLC
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
Recall
09/29/2023
Reumo Flex
n/a
n/a
botanical-be.com
Undeclared diclofenac
Public Notification
Drugs
Recall
09/29/2023
Kuka Flex Forte
n/a
n/a
botanical-be.com
Undeclared diclofenac
Public Notification
Drugs
Recall
08/31/2023
Tapee Tea
n/a
n/a
tapeetea.com
Undeclared dexamethasone and piroxicam
Public Notification
Drugs
08/22/2023
BIG GUYS Male Energy Supplement
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
08/22/2023
Mens Maximum Energy Supplement
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
08/22/2023
Round 2
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
08/22/2023
Genergy
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
08/22/2023
WeFun
n/a
n/a
amazon.com; eshoponlineusa.com
Undeclared sildenafil
Public Notification
Drugs
Recall
08/22/2023
X MAX Triple Shot Energy Honey
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
08/09/2023
Vegetal Vigra 200mg
n/a
n/a
APG Seven, Inc.
Undeclared sildenafil
Public Notification
Drugs
05/17/2023
AnnieCare Natural Repair Vaginal Capsules
Presilky dba Burhealthy.com
n/a
burhealthy.com
New drugs
Online Advisory Letter
Foods; Drugs
05/11/2023
V=GRA GOLD 500mg
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
05/08/2023
Fast-Act Rheuma Capsule
n/a
n/a
Various
Undeclared prednisone-21-acetate and piroxicam
Public Notification
Drugs
05/08/2023
New Fast-Act Rheumatism Capsule
n/a
n/a
Various
Undeclared indomethacin
Public Notification
Drugs
05/08/2023
UA-Block
n/a
n/a
Various
Undeclared indomethacin
Public Notification
Drugs
05/05/2023
Platinum 69000 Rhino 69
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
05/05/2023
Power Plus Desire
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
05/05/2023
Rhino 7S Type F3 7000
n/a
n/a
Various
Undeclared sildenafil and acetaminophen
Public Notification
Drugs
05/05/2023
Phentamene XT
n/a
n/a
Various
Undeclared DMAA
Public Notification
Foods
05/04/2023
Hard Steel 300K
n/a
n/a
Various
Undeclared tadalafil
Public Notification
Drugs
05/04/2023
Diamond Girl Lite
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
05/04/2023
Special Edition Platinum 10K
n/a
n/a
Various
Undeclared tadalafil and vardenafil
Public Notification
Drugs
05/01/2023
NORF 20
n/a
n/a
International Mail Shipments
Undeclared acetaminophen, salicylic acid, and theophylline
Public Notification
Drugs
04/19/2023
DYNAMITE Male Sexual Enhancement
n/a
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/19/2023
NUX Male Sexual Enhancement
n/a
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/19/2023
Pro Power Knight Plus 2550mg
n/a
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/13/2023
AK Forte
n/a
n/a
suprimoimports.com
Undeclared diclofenac, dexamethasone, and methocarbamol
Public Notification
Drugs
04/07/2023
Tantra Jelly Herbal Jelly for Him
n/a
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/07/2023
American Bangster Black Label Optimum Formula 4000
n/a
n/a
americanbangster.com
Undeclared tadalafil
Public Notification
Drugs
04/07/2023
American Bangster Optimum Formula 3000
n/a
n/a
americanbangster.com
Undeclared tadalafil and sildenafil
Public Notification
Drugs
04/07/2023
NORF 20
n/a
n/a
International Mail Shipments
Undeclared acetaminophen, salicylic acid, and theophylline
Public Notification
Drugs
02/16/2023
Tawon Liar
n/a
n/a
bproductline.com; etsy.com
Undeclared meloxicam, ketorolac, and dexamethasone
Public Notification
Drugs
02/08/2023
Alfia Weight Loss Capsules
n/a
n/a
alfia.com
Undeclared sibutramine
Public Notification
Drugs
02/07/2023
PrimeZen Black 6000
n/a
n/a
voltcandy.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
Recall
02/02/2023
MANNERS Energy Boost
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
12/21/2022
B.B. Clear Dark Spot Remover Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Amos Make Me White in 7 Days
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
African Queen Strong Bleaching Treatment
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Light & Natural CAROTONE Black Spot Corrector CREME B.S.C
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
HIYADY Glutatione Cream White & Bright
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Aneeza Gold Beauty Face Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Collagen Plus - Vit E Cream, Night Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Skin care & Cosmetic MSII Express Peeling
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Skin care & Cosmetic MSII Whitening Peeling
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Ling Zhi BB Whitening Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
La Tia Mana Crema Limpiadora y Curativa
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Be Be Special Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
Be Be Special Cream CCM/Yellow
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
CCM Perfect 365 White Cream
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
12/21/2022
CCM Special Cream Turmeric
n/a
n/a
Various
Skin Product with Mercury and/or Hydroquinone
Alert
Cosmetics/Drugs
11/21/2022
JACK'D Sexual Enhancement Liquid
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
11/21/2022
JACK'D Sexual Enhancement Capsules
n/a
n/a
Various
Undeclared sildenafil
Public Notification
Drugs
11/14/2022
CoQ10 Ubiquinol
Anabolic Laboratories Inc
26021 Commercentre Dr. Lake Forest, CA 92630-8853
anaboliclabs.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
PrimePolicosanol Microtabs
Anabolic Laboratories Inc
26021 Commercentre Dr. Lake Forest, CA 92630-8853
anaboliclabs.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
BPS-5
Healthy Trends Worldwide, LLC
11011 Spring Point Cir Riverview, FL 33579-4303
goldenafter50.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
Blood Pressure Support
Chambers' Apothecary
278 Lincoln Way, East Chambersburg, PA 17201
chambersapothecary.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
CoEnzyme Q10 products
Chambers' Apothecary
278 Lincoln Way, East Chambersburg, PA 17201
chambersapothecary.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
iwi Cholesterol
iwi
2800 Post Oak Blvd Suite 5858 Houston, TX 77056
iwilife.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
Cholesterol Command
BergaMet North America LLC
6445 S. Tenaya Way Suite B110 Las Vegas, NV 89113-1989
bergametna.com
New Drug/Misbranded
Warning Letter
Foods
11/14/2022
CholestAid
Essential Elements
675 N. 2800 W #101 Lindon, UT 84042
essentialelementsnutrition.com
New Drug/Misbranded
Warning Letter
Foods
09/28/2022
Wonder Pill Capsules
Proper Trade LLC/My Stellar Lifestyle
n/a
amazon.com; walmart.com
Undeclared tadalafil
Recall
Drugs
08/02/2022
SANGTER Energy Supplement, 3000mg
Distributor RFR, LLC
Miami, FL
sangter.com and retail stores
Undeclared sildenafil
Recall
Drugs
Public Notification
07/28/2022
Honeymoon Exclusive For Men & Women
n/a
n/a
Examination of imported goods
Undeclared tadalafil and sildenafil
Public Notification
Drugs
07/25/2022
Sustango
Ultra Supplement LLC
Wilmington, DE
amazon.com
Undeclared tadalafil
Recall
Drugs
07/22/2022
Lipopastilla + Gold Max
n/a
n/a
lipopastillas.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
07/15/2022
Adam's Secret Extra Strength Blue
n/a
n/a
adamssecret.com
Undeclared tadalafil
Public Notification
Drugs
07/15/2022
Adam's Secret Extra Strength Purple
n/a
n/a
adamssecret.com
Undeclared tadalafil and sildenafil
Public Notification
Drugs
07/15/2022
Adam's Secret Extra Strength Amazing Black
n/a
n/a
adamssecret.com
Undeclared tadalafil
Public Notification
Drugs
07/15/2022
Adam's Secret Extra Strength 300 Platinum (White Packaging)
n/a
n/a
adamssecret.com
Undeclared tadalafil
Public Notification
Drugs
06/27/2022
Launch Sequence Capsules
Loud Muscle Science, LLC
n/a
amazon.com, amazon.ca, ebay.com, and retail stores
Undeclared tadalafil
Recall
Drugs
06/27/2022
Launch Sequence Euphoria Capsules
Loud Muscle Science, LLC
n/a
amazon.com, amazon.ca, ebay.com, and retail stores
Undeclared tadalafil
Recall
Drugs
06/27/2022
Launch Sequence Aphrodisia Capsules
Loud Muscle Science, LLC
n/a
amazon.com, amazon.ca, ebay.com, and retail stores
Undeclared tadalafil
Recall
Drugs
04/25/2022
Kingdom Honey Royal Honey VIP
Shopaax.com
2 Burleigh Ct., Newark, DE 19702
shopaax.com
Undeclared sildenafil
Public Notification
Drugs
Warning Letter
Recall
04/25/2022
Cougar Secret Honey VIP
n/a
n/a
greenvalleyshops.com
Undeclared sildenafil
Public Notification
Drugs
04/25/2022
Medcare Golden Royal Honey
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
04/25/2022
HoneyGizer™
n/a
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
04/25/2022
ETUMAX VIP Royal Honey for Him
n/a
n/a
honeyworldusa.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/25/2022
Erkexin
n/a
n/a
aliexpress.com
Undeclared sildenafil
Public Notification
Drugs
04/25/2022
Royal Honey VIP
Thirsty Run LLC / US Royal Honey LLC
6841 Ternes St. Dearborn, MI 4812
thirstyrun.com; usroyalhoney.com
Undeclared tadalafil
Public Notification
Drugs
Warning Letter
04/25/2022
Secret Miracle Honey (for Women)
n/a
n/a
usroyalhoney.com
Undeclared sildenafil
Public Notification
Drugs
04/25/2022
Secret Miracle Honey (for Men)
n/a
n/a
etsy.com
Undeclared sildenafil
Public Notification
Drugs
04/25/2022
Vital Honey
MKS Enterprise, LLC
59 Paulison Ave. #13 Passaic, NJ 0705
wholesaleonline1.com; thirstyrun.com
Undeclared tadalafil
Public Notification
Drugs
Warning Letter
Warning Letter
Recall
04/25/2022
Helmi's Honey VIP
n/a
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
04/25/2022
X Rated Honey for Men
1am USA Incorporated dba Pleasure Products USA
6603 Crimson Lane Barnhart, MO 63012
pleasureproductsusa.com; amazon.com
Undeclared tadalafil
Public Notification
Drugs
Warning Letter
04/20/2022
Ortiga Mas Ajo Rey Extra Forte
n/a
n/a
ebay.com
Undeclared diclofenac, dexamethasone and methocarbamol
Public Notification
Drugs
Alert
04/20/2022
Ortiga Mas Ajo Rey
n/a
n/a
amazon.com
Undeclared diclofenac
Public Notification
Drugs
Alert
04/20/2022
Artri King
n/a
n/a
amazon.com, latinfoodsmarket.com, walmart.com
Undeclared dexamethasone and diclofenac
Public Notification
Drugs
Alert
Recall
Recall
03/04/2022
Wonderful Honey
n/a
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
02/10/2022
Rise Up Red Edition Capsules
Positive-Health
n/a
amazon.com
Undeclared tadalafil
Recall
Drugs
02/09/2022
Red Mammoth capsules
Celebrate Today
n/a
amazon.com
Undeclared tadalafil and sildenafil
Recall
Drugs
02/08/2022
The Red Pill
Your Favorite Shop
n/a
amazon.com
Undeclared tadalafil
Recall
Drugs
02/08/2022
MAC DADDY PURPLE capsules
ABC SALES 1 INC
n/a
amazon.com
Undeclared tadalafil
Recall
Drugs
02/08/2022
MAC DADDY RED capsules
ABC SALES 1 INC
n/a
amazon.com
Undeclared tadalafil and sildenafil
Recall
Drugs
02/04/2022
MegMan Performance Booster capsules
Junp LLC
n/a
amazon.com
Undeclared tadalafil
Recall
Drugs
01/28/2022
Hard Dawn Rise and Shine capsules
Esupplementsales, LLC
n/a
amazon.com
Undeclared tadalafil
Recall
Drugs
01/07/2022
Taewon Liar
Various Distributors
n/a
etsy.com
Undeclared meloxicam
Public Notification
Drugs
01/05/2022
Artri Ajo King
Various Distributors
n/a
amazon.com
Undeclared diclofenac
Public Notification
Drugs
Alert
01/02/2022
Nasitrol
Amcyte Pharma, Inc.
5400 Carillon Point, Kirkland, WA 98004
nasitrol.com
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/08/2021
Avaphinal
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/08/2021
Brahma Male Enhancement
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/08/2021
Hard AF!
Various Distributors
n/a
walmart.com
Undeclared sildenafil and acetaminophen
Public Notification
Drugs
News Release
12/08/2021
Helmi’s Honey VIP
Various Distributors
n/a
walmart.com
Undeclared tadalafil
Public Notification
Drugs
News Release
12/08/2021
Jaguar Power
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/08/2021
Kangaroo Intense Alpha 3000
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/08/2021
Magnum XXL 9800
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/08/2021
Pink Pussycat
Various Distributors
n/a
walmart.com
Undeclared sildenafil
Public Notification
Drugs
News Release
Recall
12/08/2021
Go On Red
Various Distributors
n/a
walmart.com
Undeclared tadalafil
Public Notification
Drugs
News Release
12/01/2021
“VitaStik” product line
VitaStik, Inc.
433 N. Camden Dr. #600, Beverly Hills, CA 90210
vitastik.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
More Information
12/01/2021
“VitaCig products”
VitaCig, Inc.
2375 Watermill Dr., Orange Park, FL 32073
vitaciggroup.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
More Information
12/01/2021
“vaporizer” and “diffuser” products
NV Nutrition, LLC
4700 140th Ave N. Suite 112, Clearwater, FL 33762
nutriair.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
More Information
12/01/2021
“B12 VITAMINVAPE”
Vitamin Vape, Inc.
6320 S. Sandhill Road, Suite 5, Las Vegas, NV 89120
vitaminvape.co
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
More Information
12/01/2021
“Caffeine Pen”
Eagle Energy USA, Inc.
27 N. 27th Street, Suite 2102, Billings, MT 59101-2347
eagle.energy
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
More Information
11/18/2021
Crocin products
Saffron Health Sciences
13 Dexter Rd, E Brunswick, NJ 08816
saffronhealthsci.com; facebook.com/saffronhealthsci/; amazon.com;
New Drug/Misbranded
Warning Letter
Foods
09/28/2021
Non-alcohol-based topical antiseptic product, microSURE™
Strategia Project Management, Inc.
1000 Jorie Blvd. Suite 370 Oak Brook, IL 60523
microsure.com; twitter.com/microsure_; facebook.com/microSURE.HandSanitizer
Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
09/22/2021
Arsyn
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street Brooklyn, NY 11223
condemnedlabz.com/; facebook.com/condemnedlabzofficial
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/22/2021
ConvictStim
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street Brooklyn, NY 11223
condemnedlabz.com/; facebook.com/condemnedlabzofficial
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/22/2021
Humaslin
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street Brooklyn, NY 11223
condemnedlabz.com/; facebook.com/condemnedlabzofficial
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/22/2021
Thyrogenic
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street Brooklyn, NY 11223
condemnedlabz.com/; facebook.com/condemnedlabzofficial
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/22/2021
DNA Dispatch
Supplement Science Corp. d/b/a Condemned Labz
2139 East 3rd Street Brooklyn, NY 11223
condemnedlabz.com/; facebook.com/condemnedlabzofficial
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/10/2021
“Glyco-Well”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Pan-Gest”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Heart-Line”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Aspara-Can”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Cherry Gold”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“H.H.S. Formula”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Brain Balance”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Passionate Pursuit”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Better Mood”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Male Prosexual”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Ear Well”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Pink Lady”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
“Eye-C”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/10/2021
Hemorr-Norm”
Holographic Health, Inc.
516 E. Market Street Kingsport, TN 37660
holographichealth.com
New Drug/Misbranded
Warning Letter
Foods
09/07/2021
“Black Indian Salve,” also referred to as “Indian Herb,” “X,” and “Black Salve”
McDaniel Water LLC
363 Ricketson Road Amistad, NM 88410
mcdanielwater.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
09/07/2021
CuraLin
Radhanite, LLC d/b/a Curalife Ltd
208 Paterson Plank Rd. Union City, NJ 07087-2826
curalife.com/; instagram.com/curalife/ and https://www.facebook.com/curalife/
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
Sugar Balance
Aceva, LLC
624 West Glen Ave. Peoria, IL 61614
aceva.com/; twitter.com/acevahealth and https://www.facebook.com/acevanutrition
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
Diabetes Support
Ar-Rahman Pharm LLC
14625 Baltimore Ave., Suite 885 Laurel, MD 20707
ar‐rahmahpharm.com/; instagram.com/arrahmahpharm/; facebook.com/ArRahmahPharm
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Lysulin Weight Loss Shake”
Lysulin, Inc.
4930 Bradshaw Ct. San Diego, CA 92130
lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Lysulin Diabetes and Prediabetes Chewables”
Lysulin, Inc.
4930 Bradshaw Ct. San Diego, CA 92130
lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Lysulin Diabetes and Prediabetes Liquid”
Lysulin, Inc.
4930 Bradshaw Ct. San Diego, CA 92130
lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Lysulin Diabetes and Prediabetes Capsules”
Lysulin, Inc.
4930 Bradshaw Ct. San Diego, CA 92130
lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Lysulin Diabetes and Prediabetes Powder”
Lysulin, Inc.
4930 Bradshaw Ct. San Diego, CA 92130
lysulin.com; instagram.com/lysulin_usa/; facebook.com/lysulindiabetesmanagement
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Berry Gen Sugar Control”
Live Good Inc.
860 NW 27th St. Suite 051-51425 Miami, FL 33122
berrygen.com/; facebook.com/ColagenoBerryGenRestore/; instagram.com/berrygenrestore/
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
"GLUCOTYPE2”
Phytag Labs
12600 Hill Country Boulevard Suite R-275 Bee Cave, TX 78738
phytagelaboratories.com; amazon.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Diabetic Support Formula”
Nuturna International LLC
390 North Orange Ave. Suite 2300 Orlando, FL 32801
nuturna.com; amazon.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Diabetes Doctor Pre-Diabetes”
Pharmaganics LLC
8475 Parley Lake Rd Waconia, MN 55387
diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
“Diabetes Doctor Blood Sugar 24 Hour”
Pharmaganics LLC
8475 Parley Lake Rd Waconia, MN 55387
diabetesdoctor.com; facebook.com/naturaldiabetesdoctor; instagram.com/diabetesdoctor/
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
DiabetesSupport
Metamune Inc
8001 S 194th St. Kent, WA 98032-1126
bodymune.com/; facebook.com/Bodymune/; amazon.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
09/07/2021
Diabalance Diabetes Supplement
Holistic Healer & Wellness Center, Inc.
3998 Clippert St. P.O. Box 23017 Dearborn, MI 48123
holistichealeronline.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Muscle Test
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Banish
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Ketogenic Diet Aid
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Keto Friendly Collagen
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Exile Euphoric Weight Loss
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Exile Super Shock
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Havok Hardcore
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/31/2021
Keto Pump in Watermelon and Grape Flavors
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B Cedar Creek, TX 78612-3689
americanmetabolix.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
08/26/2021
Fibrolief Support Formula
Fibromyalgia Treatment Group - FTG, LLC
1236 Lone Creek Drive Eagle, ID 83616
fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief
New Drug/Misbranded
Warning Letter
Foods
08/26/2021
Nerve Renew
Fibromyalgia Treatment Group - FTG, LLC
1236 Lone Creek Drive Eagle, ID 83616
fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief
New Drug/Misbranded
Warning Letter
Foods
08/26/2021
Neuro Boost Optimizer
Fibromyalgia Treatment Group - FTG, LLC
1236 Lone Creek Drive Eagle, ID 83616
fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief
New Drug/Misbranded
Warning Letter
Foods
08/26/2021
Immune Support
Fibromyalgia Treatment Group - FTG, LLC
1236 Lone Creek Drive Eagle, ID 83616
fibromyalgiatreatmentgroup.com/landers/1/; fibrolief.com; neuropathytreatmentgroup.com; nerverenew.com; facebook.com/fibrolief
New Drug/Misbranded
Warning Letter
Foods
08/24/2021
ISM5 Invisi Smart Mask
Invisi Smart Technologies UK LTD
112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart
Adulterated and Misbranded Products Related to Coronavirus Disease 2019
Warning Letter
Devices
08/24/2021
ISM5 Invisi Smart Mask (Black Edition)
Invisi Smart Technologies UK LTD
112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart
Adulterated and Misbranded Products Related to Coronavirus Disease 2019
Warning Letter
Devices
08/24/2021
ISM30 Invisi Smart Mask
Invisi Smart Technologies UK LTD
112 Cumberland House80 Scrubs Lane London NW10 6RF United Kingdom
invisismart.com/; shop.invisismart.com/; twitter.com/InvisiSmart
Adulterated and Misbranded Products Related to Coronavirus Disease 2019
Warning Letter
Devices
08/19/2021
“Patanjali Coronil Kit” (aka “Patanjali Divya Swasari Coronil Kit”)
Mahita, LLC dba PushMyCart
415 Hillingdon Way Suwanee, GA 30024
pushmycart.com; facebook.com/pushmycartglobal
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/19/2021
“Dr. Reckeweg Arsenic Album Dilution 30 CH"
Mahita, LLC dba PushMyCart
415 Hillingdon Way Suwanee, GA 30024
pushmycart.com; facebook.com/pushmycartglobal
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/19/2021
“SBL Arsenicum Album Dilution 30 CH"
Mahita, LLC dba PushMyCart
415 Hillingdon Way Suwanee, GA 30024
pushmycart.com; facebook.com/pushmycartglobal
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/19/2021
“Kerala Ayurveda Balarishtam"
Mahita, LLC dba PushMyCart
415 Hillingdon Way Suwanee, GA 30024
pushmycart.com; facebook.com/pushmycartglobal
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/19/2021
“Kottakkal Balarishtam”
Mahita, LLC dba PushMyCart
415 Hillingdon Way Suwanee, GA 30024
pushmycart.com; facebook.com/pushmycartglobal
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/18/2021
Themra Epimedyumlu Bitkisel Karisimli Macun
Various Distributors
n/a
Examination of imported goods - shipment addressed to an Amazon fulfillment center
Undeclared sildenafil
Public Notification
Drugs
08/10/2021
Various salt scrub products
Secret of the Islands
5326 Bush River Rd. Columbia, SC 29212
secretoftheislands.com; facebook.com/SecretoftheIslands
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/06/2021
Modified Perilla & Mentha
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Empowered Cordyceps
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Empowered Reishi
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
AllerEase
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Empowered Eleuthro
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Sui Bian Guo
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Chinese Herbal Shampoo
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Jade Dew Ointment
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Stop Pain Tincture
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Dr. Bob’s Medicated Oil
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Cut & Sore Ointment
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
E-C-Z Ointment
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Organic Cactus Seed (Prickly Pear) Oil Antioxidant Facial Serum
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Skin Soothing Ointment
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
Dragon’s Blood Liniment
Blue Poppy Enterprises Inc
4804 SE 69th Avenue Portland, OR 97206
bluepoppy.com; peopleherbs.com; facebook.com/ PeoplesHerbs/; twitter.com/peoples herbs; instagram.com/peoples_herbs/;& amazon.com
New Drug/Misbranded
Warning Letter
Foods
08/06/2021
"Genesis Ultra Gold"
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
10108 NW 77th Street Doral, FL 33178
fastweightlossgarcinia.com; ketoultraslimplus.com; facebook.com/genesisultraslim; twitter.com/genesis_slim; instagram.com/genesis_slim/
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
08/03/2021
Non-alcohol-based consumer antiseptic nasal product, "NanoBio® Protect Over-The-Counter Nasal Antiseptic"
Blue Willow Biologics
2311 Green Road Ann Arbor, MI 48105
nanobioprotect.com; bluewillow.com; cvs.com/shop/nanobio-protect-nasal-antiseptic-prodid-160333
Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
08/02/2021
365 Skinny High Intensity Pills
Je Dois L’avoir Boutique
n/a
jedoisavoir2020.com
Undeclared sibutramine
Recall
Drugs
08/02/2021
365 Skinny Emergency Boutique
Je Dois L’avoir Boutique
n/a
jedoisavoir2020.com
Undeclared sibutramine
Recall
Drugs
07/29/2021
Neutralization Antibody Test kit (Colloidal Gold, Fluorescent, Elisa)
Lepu Medical Technology -Beijing- Co., Ltd.
No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
n/a
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/29/2021
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Lepu Medical Technology -Beijing- Co., Ltd.
No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
n/a
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/29/2021
Saliva Antigen Rapid Test
Lepu Medical Technology -Beijing- Co., Ltd.
No. 37 Chaoqian Rd.Changping Qu Beijing Shi,China
n/a
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/28/2021
Melatonin
Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
25050 Peachland Ave #105 Newhall, CA 91321
getbetterxshop.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
07/28/2021
Nitric Oxide Support
Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.
25050 Peachland Ave #105 Newhall, CA 91321
getbetterxshop.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
07/26/2021
Hydro Pinapple [sic] Burn
Max Health; eBay Seller - jongu 4308
Houston, TX
ebay.com
Undeclared sibutramine and desisobutylbenzylsibutramine
Public Notification
Drugs
Recall
07/26/2021
“COVx-RDA Nasal Antigen Test”
Vivera Pharmaceuticals, Inc.
26021 Pala Drive - St A Mission Viejo, CA 92691
viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/26/2021
“COVxRDA Saliva Antigen Test”
Vivera Pharmaceuticals, Inc.
26021 Pala Drive - St A Mission Viejo, CA 92691
viveracovid19.com/covx-rda/; viverapharmaceuticals.com/products/
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/26/2021
VIVERA + OMECARE Home Specimen Collection Kit
Vivera Pharmaceuticals, Inc.
26021 Pala Drive - St A Mission Viejo, CA 92691
hometestbox.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/23/2021
Organic Blueberry White & Green Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Clean Green Energy Detox Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Tokusen Hinshucha Fuji Midori Green Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Vibrant Green Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Caffeine-Free Herbal Energy Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Ignited Oolong Slimming Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Power Puer Aged Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/23/2021
Silver Tranquility White Tea
TeaTaze, LLC
1203 N Fieldcrest St Wichita, KS 67212
teataze.com; facebook.com/teatazetea
New Drug/Misbranded
Warning Letter
Foods
07/22/2021
“Regular Strength Nasadol CBD Nasal Spray”
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“Extra Strength Nasadol CBD Nasal Spray”
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“Pain Relief Roll-On”
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“CBD Oil Tincture” (500 mg and 1500 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“Sour Gummy Worms” (250 mg and 500 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“CBD Gummy Worms” (250 mg and 500 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“CBD Peach Rings” (250 mg and 500 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“Watermelon Slices” (250 mg, 500 mg, and 1000 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“CBD Gummy Bears” (500 mg and 1000 mg)
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“1,000mg Canine CBD Oil”
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
“CBD Dog Treats”
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A Madison, WI 53719
biospectrumcbd.com; nasadol.com; facebook.com/BioSpectrumCBD; instagram.com/biospectrum.cbd/
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2021
Miss Slim
HIS
Palisades Park, NJ
missslimusa.com
Undeclared sibutramine
Recall
Drugs
07/20/2021
Lion’s Mane
Brilliant Enterprises LLC
621 Main Street, Unit 182Gaylord, MI 49735
levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms
Unapproved New Drugs/Misbranded
Warning Letter
Foods
07/20/2021
BoomChaga
Brilliant Enterprises LLC
621 Main Street, Unit 182Gaylord, MI 49735
levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms
Unapproved New Drugs/Misbranded
Warning Letter
Foods
07/20/2021
CordaCex
Brilliant Enterprises LLC
621 Main Street, Unit 182Gaylord, MI 49735
levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms
Unapproved New Drugs/Misbranded
Warning Letter
Foods
07/20/2021
LVL:MAX
Brilliant Enterprises LLC
621 Main Street, Unit 182Gaylord, MI 49735
levelupmushrooms.com; instagram.com/levelupmushrooms; twitter.com/LvlUpMushrooms
Unapproved New Drugs/Misbranded
Warning Letter
Foods
07/20/2021
“Germaphobe’s Delight Spray”
Jordan’s Crossing Herbal Connections
568 County Road 2307 Barnsdall, OK 74002
jordanscrossing.net; youtube.com/watch?v=dWCJdjcjbfM
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
07/19/2021
Alpha Male Plus
Alpha Male Plus
n/a
alphamaleplus.us
Undeclared tadalafil
Recall
Drugs
07/14/2021
Diabetic Patch (aka Herbal Diabetic Patch)
Healthy Livin' Solutions
9169 W State St #628 Garden City, Idaho 83714
healthylivin.solutions
New Drug
Online Advisory Letter
Drugs
07/09/2021
X Rated Honey For Men
Various Distributors
n/a
adameve.com
Undeclared tadalafil
Public Notification
Drugs
07/09/2021
“COVIGEN AG-1 Covid-19 Self Detection Kit”
Biopolygen Corp.
2207 East Carson St Carson, CA 90810
biopolygen.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/09/2021
“COVIDEX AB-1 Covid-19 Self Detection Kit”
Biopolygen Corp.
2207 East Carson St Carson, CA 90810
biopolygen.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/09/2021
“COVID-19 Antigen and Antibody Combo Set”
Biopolygen Corp.
2207 East Carson St Carson, CA 90810
biopolygen.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/09/2021
“Saliva Test Kit”
USH Diagnostics, Inc./covidinstanttest.net
3456 E. 155th St. Kansas City, MO 64147
covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/09/2021
“Rapid 10 Minute Antigen Test”
USH Diagnostics, Inc./covidinstanttest.net
3456 E. 155th St. Kansas City, MO 64147
covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/09/2021
“Rapid Dual Antibody Test”
USH Diagnostics, Inc./covidinstanttest.net
3456 E. 155th St. Kansas City, MO 64147
covidinstanttest.net; ushealthdiagnostics.com/; facebook.com/covid19instanttest; twitter.com/covidathometest; instagram.com/covid19instanttest
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
07/08/2021
Immune Booster
3RD Day Nutraceuticals, LLC
225 N Main St, Suite 404 Bristol, CT 06010
3rddaynutra.com
New Drug/Misbranded
Warning Letter
Foods
07/08/2021
Allergy Support
3RD Day Nutraceuticals, LLC
225 N Main St, Suite 404 Bristol, CT 06010
3rddaynutra.com
New Drug/Misbranded
Warning Letter
Foods
07/08/2021
Inflammatory Response Support
3RD Day Nutraceuticals, LLC
225 N Main St, Suite 404 Bristol, CT 06010
3rddaynutra.com
New Drug/Misbranded
Warning Letter
Foods
07/08/2021
Revive & Recover
3RD Day Nutraceuticals, LLC
225 N Main St, Suite 404 Bristol, CT 06010
3rddaynutra.com
New Drug/Misbranded
Warning Letter
Foods
07/07/2021
Halodine nasal and oral “sanitizer” product lines that include, Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse
Halodine, LLC
111 NE 1st St, Suite 806 Miami, FL 33132-2506
halodine.com; shop.halodine.com; twitter.com/TheHalodine; facebook.com/halodine
Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
07/01/2021
Genesis Ultra Slim Gold
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
10108 NW 77th StreetDoral, FL 33178
fastweightlossgarcinia.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
Warning Letter
07/01/2021
High Vitality Full Spectrum Liquid Multi-Vitamin
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
High Vitality Caps
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Best Cholesterol Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Blood Sugar Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Maximum Stress Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Complete Joint Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Natural Anti-Inflammatory Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Best Immune Support
Phoenix Nutritionals, Inc.
4727 Terrace Drive San Diego, CA 92116-2515
phoenixvitamins.com; healthyinformation.com; facebook.com/phoenixnutritionalsinc/
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Altitude RX
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
brlsports.com
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Flexify
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
brlsports.com
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Calm Legs
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
nativeorigins.com; brlscience.com; facebook.com/mynativeorigins
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Collagen Peptides
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
nativeorigins.com; brlscience.com; facebook.com/mynativeorigins
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Prohemia
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
nativeorigins.com; brlscience.com; facebook.com/mynativeorigins
New Drug/Misbranded
Warning Letter
Foods
07/01/2021
Trimmunity
Biomedical Research Laboratories, LLC
7590 Fay Ave Suite 202 La Jolla, CA 92037-4885
nativeorigins.com; brlscience.com; facebook.com/mynativeorigins
New Drug/Misbranded
Warning Letter
Foods
06/30/2021
365 SKINNY High Intensity
Je Dois Lavoir LLC
n/a
jedoisavoir2020.com; facebook.com/jdl2020; instagram.com/j_d_l2020
Undeclared sibutramine
Public Notification
Drugs
Recall
Warning Letter
06/23/2021
ProbioticXL
Great Healthworks, Inc.
4150 SW 28th Way Fort Lauderdale, FL 33312-5201
greathealthworks.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
06/23/2021
OmegaXL
Great Healthworks, Inc.
4150 SW 28th Way Fort Lauderdale, FL 33312-5201
greathealthworks.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
06/22/2021
Immune Builder
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
High Risk Environment Pack- NO SYMPTOMS
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Anti-Viral Herbal Formula
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Anti-Viral Herbal Pack – ACUTE ILLINESS
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Kitchen Sink
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Lung Formula Dry Cough
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Lung Formula Wet Cough
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Colloidal Silver
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/22/2021
Post COVID-19 Recovery
Pacific Center of Health/Pacific Center of Health & Acupuncture
8555 Aero Dr. Suite 107 San Diego, CA 92123
pacificcenterofhealth.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
06/10/2021
Super Tonic
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Respiratory Aid
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Wild Cherry Honey Syrup
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Ivy Oaky
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Jewelweed Spray Combo Pack
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Jewelweed Spray
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Prostate Health
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Kidney/Bladder
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
Bone & Tissue Connect
Natural Hope Herbals, LLC
670 Phillips Road Millersburg, PA 17061-9044
naturalhopeherbals.com
New Drug/Misbranded
Warning Letter
Foods
06/10/2021
SARS-CoV-2 Antigen Rapid Qualitative Test
Innova Medical Group, Inc.
800 E. Colorado Blvd., Suite 288 Pasadena, CA 91101
n/a
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
06/07/2021
Travel Care Probiotic
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Sleep•Essence
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Cardio•Essence
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Grape Seed Extract Plus
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Elderberry+, Elderberry Crystals
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Flor•Essence
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Hydro-Therm Pumpkin Oil
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Pumpkin Oil
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/07/2021
Mãnuka Honey
Flora Inc
805 E. Badger Rd. Lynden, WA 98264-9502
florahealth.com/us; pinterest.com/florahealth/
New Drug/Misbranded
Warning Letter
Foods
06/04/2021
Miss Slim
Various Distributors
n/a
amazon.com
Undeclared sibutramine
Public Notification
Drugs
06/04/2021
Adam’s Secret Extra Strength 2000
Various Distributors
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
05/27/2021
Berberine
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Echinacea
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
European Elderberry
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Milk Thistle
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Lion’s Mane Mushroom
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Turmeric Curcumin
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Fish Oil
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Green Lipped Mussels
Fresh Nutrition Inc
23860 Nicole Way Yorba Linda, CA 92887-5626
fresh-nutrition.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/27/2021
Various chlorine dioxide products, including “OCLO 3000E”
OCLO LLC/OCLO Nanotechnology Science
220 SW 9th Ave, #506 Hallandale, FL 33009
dioxidodecloro.us; facebook.com/Hallandale.Beach.2018/; oclo.ecrater.com/index.php
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
05/26/2021
Super Naturals brand IBSolution
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
1309 ½ S. Roxbury Dr. Los Angeles, CA 90035
supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief
New Drug/Misbranded
Warning Letter
Foods
05/26/2021
Premium Probiotic
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
1309 ½ S. Roxbury Dr. Los Angeles, CA 90035
supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief
New Drug/Misbranded
Warning Letter
Foods
05/26/2021
Sleep Solution
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
1309 ½ S. Roxbury Dr. Los Angeles, CA 90035
supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief
New Drug/Misbranded
Warning Letter
Foods
05/26/2021
Joint Solution
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
1309 ½ S. Roxbury Dr. Los Angeles, CA 90035
supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief
New Drug/Misbranded
Warning Letter
Foods
05/26/2021
Ultra Omega Fish Oil
JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health
1309 ½ S. Roxbury Dr. Los Angeles, CA 90035
supernaturalshealth.com; ibsformula.com; amazon.com; facebook.com/supernaturalshealth; facebook.com/ibsrelief
New Drug/Misbranded
Warning Letter
Foods
05/24/2021
Brazilian Propolis Extract
Beauty & Spa Concepts, DBA Beenefits
10765 Southwest 108th Ave. #308 Miami, FL 33176
beenefits.com; instagram.com/beenefits/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
05/24/2021
CoronaBox
Everything Health LLC
1445 293rd Ave NE Carnation, WA 98014
ssnaturalhealing.com; facebook.com/ssdallastx/; instagram.com/tamikamoseley/; twitter.com/sicklesolution
Unapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19)
Warning Letter
Foods
05/20/2021
“NaturaCure”
NS Products, Inc.
11721 State Ave Marysville, WA 98271
naturacure.net
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“OVOENERGEN™ CoenzymeQ10”
Fertility Nutraceuticals LLC
21 E 69th St New York, NY 10021
fertilitynutraceuticals.com; fertilitysupplementstore.com
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“FERTINATAL® DHEA”
Fertility Nutraceuticals LLC
21 E 69th St New York, NY 10021
fertilitynutraceuticals.com; fertilitysupplementstore.com
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“CONFLAM- Forte™”
Fertility Nutraceuticals LLC
21 E 69th St New York, NY 10021
fertilitynutraceuticals.com; fertilitysupplementstore.com
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“CONCEPTION MEN Male Fertility”
EU Natural Inc.
2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052
store.eunatural.com; instagram.com/eunatural/
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“CONCEPTION Female Fertility Prenatal”
EU Natural Inc.
2654 W Horizon Ridge Pkwy Ste B5-93 Henderson, NV 89052
store.eunatural.com; instagram.com/eunatural/
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“ConceiveEasy”
LeRoche Benicoeur dba ConceiveEasy
1130 Fremont Blvd #301 Seaside, CA 93955
conceiveeasy.com
New Drug/Misbranded
Warning Letter
Foods
05/20/2021
“FertilHerb for Womenr”
Sal Nature LLC/FertilHerb
1621 Central Ave Cheyenne, WY 82001-4531
fertilherb.com
New Drug/Misbranded
Warning Letter
Foods
05/19/2021
“BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug”
BGP, LLC
2118 Wilshire Blvd Santa Monica, CA 90403
biocence.com; facebook.com/Biocence; instagram.com/biocence
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
05/12/2021
Lipodrene w/25mg Ephedra Extract Dietary Supplement
Hi-Tech Pharmaceuticals. Inc
Norcross, GA
n/a
Presence of 1,4-dimethylamylamine (DMAA)
Recall
Foods
05/10/2021
Collagen Endurance Plus
Great Lakes Gelatin Company
253 Commerce Dr., Ste 101 Grayslake, IL 60030
greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/
New Drug/Misbranded
Warning Letter
Foods
05/10/2021
Keto Collagen + MCT
Great Lakes Gelatin Company
253 Commerce Dr., Ste 101 Grayslake, IL 60030
greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/
New Drug/Misbranded
Warning Letter
Foods
05/10/2021
Collagen Hydrolysate (10 oz unflavored and vanilla, mixed berry, lemon + lime, apple + cucumber, chocolate, and chai flavors, 16 oz unflavored, Convenience Pack (20 count unflavored), 8lb unflavored)
Great Lakes Gelatin Company
253 Commerce Dr., Ste 101 Grayslake, IL 60030
greatlakesgelatin.com facebook.com/greatlakesgel/; pinterest.com/greatlakesgel/
New Drug/Misbranded
Warning Letter
Foods
05/06/2021
DISINFECT™ & SHIELD HAND SANITIZER non-alcohol based hand sanitizer products
Disinfect & Shield
1616 Fountain View Drive Houston, TX 77057
disinfectandshield.com
Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
05/06/2021
Non-alcohol based hand sanitizer products
Covalon Technologies Inc.
1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canada
covaguard.com; instagram.com/covaguard/; facebook.com/covaguard/
Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
05/04/2021
GenBody COVID-19 IgM/IgG test
Baltimore Beauty Security Square Mall
6901 Security Square Blvd. #343 Baltimore, MD 21244
n/a
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
05/04/2021
GenBody COVID-19 Ag test
Baltimore Beauty Security Square Mall
6901 Security Square Blvd. #343 Baltimore, MD 21244
n/a
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
04/29/2021
Tummy Tuck Max
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
04/29/2021
Enerup Premium
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
04/29/2021
ErectMax
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
04/29/2021
Vital Sex
Various Distributors
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
04/29/2021
Iodine Detoxified
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/29/2021
Karma Cleanse
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/29/2021
E3 Digestive Enzymes Supreme
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/29/2021
Diatomaceous Earth Powder (DE)
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/29/2021
E3 Renew Me/B.G. Blue Green Algae
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/29/2021
Clinic’s Choice CLO2
Crown Wellness, Inc.
421 Grand Concourse #1 Miami Shores, FL 33183 9999 NE 2 Ave, Suite 209E Miami Shores, FL 33138
crownwellness.com
New Drug/Misbranded
Warning Letter
Foods
04/28/2021
Herpes Protocol Ultimate Kit
The Underground Cure
P.O. Box 1111 Snellville, GA 30078
theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
New Drug
Online Advisory Letter
Foods; Drugs
04/28/2021
Herpes Protocol Vitamin Kit
The Underground Cure
P.O. Box 1111 Snellville, GA 30078
theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
New Drug
Online Advisory Letter
Foods; Drugs
04/28/2021
Olive Leaf Extract
The Underground Cure
P.O. Box 1111 Snellville, GA 30078
theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
New Drug
Online Advisory Letter
Foods; Drugs
04/28/2021
DMSO Liquid 70/30
The Underground Cure
P.O. Box 1111 Snellville, GA 30078
theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
New Drug
Online Advisory Letter
Foods; Drugs
04/28/2021
Gentiana Complex
The Underground Cure
P.O. Box 1111 Snellville, GA 30078
theundergroundcure.com, twitter.com.com/Undergroundcure, youtube.com/c/TheUndergroundCureUGC
New Drug
Online Advisory Letter
Foods; Drugs
04/27/2021
“HM-FORMULA”
NeuroHydrate LLC
4637 Main St, Unit 5 Bridgeport, CT 06606-1838
neurohydrate.com/
New Drug/Misbranded
Warning Letter
Foods
04/21/2021
Pixie Dust Magnesium
DRF LLC
United States
doctorfarrah.com; drfarrah.online
New Drug/Misbranded
Warning Letter
Foods
04/21/2021
Mega-Dose Vitamin C
DRF LLC
United States
doctorfarrah.com; drfarrah.online
New Drug/Misbranded
Warning Letter
Foods
04/21/2021
Boston C
DRF LLC
United States
doctorfarrah.com; drfarrah.online
New Drug/Misbranded
Warning Letter
Foods
04/21/2021
“Red 65”
North American Hirudin Biotech Products Inc.
2531 Broadway, Suite A Everett, WA 98201
ushirudin.com/; naturalhirudin.com/; buyred65.com/
New Drug/Misbranded
Warning Letter
Foods
04/21/2021
“Hirudin”
North American Hirudin Biotech Products Inc.
2531 Broadway, Suite A Everett, WA 98201
ushirudin.com/; naturalhirudin.com/; buyred65.com/
New Drug/Misbranded
Warning Letter
Foods
04/15/2021
Balanced Kollagen
Molecular BioLife International, Inc.
200 W 16th St Bldg B Sheldon, IA 51201-2008
molecularbiolife.com
New Drug/Misbranded
Warning Letter
Foods
04/15/2021
Shark 2 Collagen
Molecular BioLife International, Inc.
200 W 16th St Bldg B Sheldon, IA 51201-2008
molecularbiolife.com
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
“COVID-19 Formula”
Trinity Natural Health & Pain Management, Inc.
1100 NE 125th Street, Suite #203A North Miami, FL 33161
trinity-naturalhealth.com/; facebook.com/TrinityNaturalSupplements
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
04/13/2021
Apple Cider Vinegar Capsules
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Ashwagandha Capsules
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Garcinia Cambogia Capsules
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Premium Collagen Peptides Capsules
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Elderberry Gummies
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Omega 3 Fish Oil Softgels
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
Turmeric Curcumin with Bioperin Capsules
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475 San Francisco, CA 94115
orphicnutrition.comand; amazon.com/stores/Orphic+Nutrition+/page/CB818446-8B2D-4C42-B7B9-8D69797835C2?ref_=ast_bln
New Drug/Misbranded
Warning Letter
Foods
04/13/2021
“Covid-19 Test Kit”
Anytime COVID Test LLC
6615 West Boynton Beach Blvd., #181 Boynton Beach, FL 33437
anytimecovidtest.com; mycovidtester.com; gotcovidtests.com; covidtestyou.com buymycovidtest.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
04/08/2021
Alterra Sili-Mer G5
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Anemia
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Cancer (Piptopet)
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Cancer (Specific Remedy)
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Cataract-L
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Fracture
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Heart
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Heart Murmur
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Heartworm
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Hip Dysplasia
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Parvopet
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Seizurepet
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Thyroidpet
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
Virus Defense Kit, which includes your Immunopet, Silverpet, and Cordyceps
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/08/2021
White Blood Cells
Groupe Cyrenne Inc. dba HomeoAnimal
1205 Des Chataigniers Quebec QC G3G 3C4 Canada
homeoanimal.com; facebook.com/homeoanimal
Unapproved New Animal Drug Products
Warning Letter
Veterinary
04/07/2021
Silver Soul Immune Support
Allure Imports
405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs, Veterinary
04/07/2021
Silver Soul Body Spray
Allure Imports
405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs, Veterinary
04/07/2021
Vitality C60
Allure Imports
405 E Easterday Ave., Unit 2, Sault Sainte Marie, MI 49783
facedoctor.ca; vitalityc60.com allureimports.com facebook.com/facedoctorca/; facebook.com/vitalityc60; instagram.com/facedoctor.ca/; twitter.com/FaceDoctorRx/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs, Veterinary
04/07/2021
Puriton topical skin products
About Mineral
3063 W. Chapman Ave., #6301 Orange, CA 92868
aboutmineral.com; facebook.com/aboutmineral; instagram.com/about_mineral/;
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
04/07/2021
Colox
Unived Inc
16491 Scientific Way Irvine, CA 92618
unived.us/; amazon.com
New Drug/Misbranded
Warning Letter
Foods
04/07/2021
CalDveg
Unived Inc
16491 Scientific Way Irvine, CA 92618
unived.us/; amazon.com
New Drug/Misbranded
Warning Letter
Foods
04/07/2021
B12+D3
Unived Inc
16491 Scientific Way Irvine, CA 92618
unived.us/; amazon.com
New Drug/Misbranded
Warning Letter
Foods
04/07/2021
D3+K2-7
Unived Inc
16491 Scientific Way Irvine, CA 92618
unived.us/; amazon.com
New Drug/Misbranded
Warning Letter
Foods
04/06/2021
“Rapid COVID-19 Antigen Self Test Kit”
Sethi Laboratories
17290 Preston Road Suite 300 Dallas, TX 75252
sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUS
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
04/06/2021
“Rapid COVID-19 Antibody Self Test Kit”
Sethi Laboratories
17290 Preston Road Suite 300 Dallas, TX 75252
sethilaboratories.com; facebook.com/sethilabs; instagram.com/p/CGC8yKEHXZO; twitter.com/SethiLabsUS
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
04/01/2021
Purity Essential Oil Blend products
Natural Adventure, LLC
13765 SW 32nd Street Miramar, FL 33027
mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
04/01/2021
Purity Sanitizer with 70% Alcohol
Natural Adventure, LLC
13765 SW 32nd Street Miramar, FL 33027
mynaturaladventure.com; facebook.com/MyNatAdventure; instagram.com/mynatadventure/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/30/2021
Immune Bio Green Cell
Immune & Genetics Protocols, LLC
1655 SW 63rd ST RD Ocala, FL 34476
biogreencell.com; facebook.com/BioGreenCell/
New Drug/Misbranded
Warning Letter
Devices
03/29/2021
Formula I
Nature's Pharmacy, LLC
1565 195th Avenue Bloomer, WI 54724
naturespharmacyllc.com
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Formula II
Nature's Pharmacy, LLC
1565 195th Avenue Bloomer, WI 54724
naturespharmacyllc.com
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Formula III
Nature's Pharmacy, LLC
1565 195th Avenue Bloomer, WI 54724
naturespharmacyllc.com
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Formula IV
Nature's Pharmacy, LLC
1565 195th Avenue Bloomer, WI 54724
naturespharmacyllc.com
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Formula V
Nature's Pharmacy, LLC
1565 195th Avenue Bloomer, WI 54724
naturespharmacyllc.com
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Magnesium Transdermal Patches
Better Supplement Solutions Inc. dba XanFree
105 Overton St Deer Park, NY 11729
xanfree.com; facebook.com/getxanfree
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Tranquil Blend
Better Supplement Solutions Inc. dba XanFree
105 Overton St Deer Park, NY 11729
xanfree.com; facebook.com/getxanfree
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Tranquil Blend + Magnesium Transdermal Combo
Better Supplement Solutions Inc. dba XanFree
105 Overton St Deer Park, NY 11729
xanfree.com; facebook.com/getxanfree
New Drug
Online Advisory Letter
Foods; Drugs
03/29/2021
Yin-Yang Essence Men Power
Various Distributors
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/29/2021
Furious X 1350
Various Distributors
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/29/2021
Zing Plus
Various Distributors
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
03/25/2021
“Akcutest COVID-19 Antibody Test”
Ikcon Investments, Inc dba Ikcon Medical
14653 Caminito Lazanja San Diego, CA 92127
ikconmedical.com; akcutestshop.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
03/25/2021
“Lumigenik COVID-19 Antigen Rapid Test”
Ikcon Investments, Inc dba Ikcon Medical
14653 Caminito Lazanja San Diego, CA 92127
ikconmedical.com; akcutestshop.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
03/24/2021
“COVID-19 IgM/IgG Rapid Test”
Tresmonet Technologies, Inc., TM Testing, Inc. dba TM Technologies, Inc./TM Labs
424 S. Roadway New Orleans, LA 70124
tmtestkits.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
03/19/2021
Lipotriad Vision Support Plus
Lipotriad LLC
5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad
New Drug/Misbranded
Warning Letter
Foods
03/19/2021
Lipotriad Dry Eye
Lipotriad LLC
5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad
New Drug/Misbranded
Warning Letter
Foods
03/19/2021
Lipotriad Adult 50+
Lipotriad LLC
5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad
New Drug/Misbranded
Warning Letter
Foods
03/19/2021
Lipotriad Visionary
Lipotriad LLC
5 Sentry Parkway East Suite 210 Blue Bell, PA 19422
lipotriadvitamins.com; facebook.com/LipotriadVitamins; twitter.com/Lipotriad
New Drug/Misbranded
Warning Letter
Foods
03/18/2021
“Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)”
Block Scientific
22 Sawgrass Drive Bellport, NY 11713
blockscientificstore.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
03/18/2021
“QUIKPACII COVID-19 ANTIBODY TEST KIT”
Block Scientific
22 Sawgrass Drive Bellport, NY 11713
blockscientificstore.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
03/18/2021
"Magnesium Oil Spray"
BioLyte Laboratories, LLC
310 Northern Dr. NW, Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/18/2021
"Pain Relief Cream"
BioLyte Laboratories, LLC
310 Northern Dr. NW Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/18/2021
"Therapeutic Pain Gel"
BioLyte Laboratories, LLC
310 Northern Dr. NW, Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/18/2021
"Silver Liquid Supplement"
BioLyte Laboratories, LLC
310 Northern Dr. NW, Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/18/2021
"Silver Gel with Aloe"
BioLyte Laboratories, LLC
310 Northern Dr. NW, Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/18/2021
"Silver Gel"
BioLyte Laboratories, LLC
310 Northern Dr. NW, Grand Rapids, MI 49534
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/16/2021
Fucoidan
Anna Health, LLC
9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
annahealth.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Prostate Health
Anna Health, LLC
9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
annahealth.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Children Liquid Vitamins
Anna Health, LLC
9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
annahealth.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Immune Health
Anna Health, LLC
9724 N. Armenia Ave. Suite 400 Tampa, FL 33612-7550
annahealth.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Fucoidan
Duoc Thao Tre Xanh, LLC
9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
duocthaotrexanh.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Papaya Leaf Extract
Duoc Thao Tre Xanh, LLC
9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
duocthaotrexanh.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Ganoderma Lucidum Red Reishi Mushroom
Duoc Thao Tre Xanh, LLC
9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
duocthaotrexanh.com
New Drug/Misbranded
Warning Letter
Foods
03/16/2021
Immune Health
Duoc Thao Tre Xanh, LLC
9724 N. Armenia Ave. Suite 401a, Tampa, FL 33612-7550
duocthaotrexanh.com
New Drug/Misbranded
Warning Letter
Foods
03/15/2021
“ELIXICURE PAIN RELIEF with CBD” products
Honest Globe, Inc.
3605 West Macarthur Boulevard, Suite 701 Santa Ana, CA 92704-6845
N/A
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
03/12/2021
“ROSE FREQUENCY TONGUE TINCTURE”
Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
351 NW Pleasant View Dr, Grants Pass OR 37526
ravenscroftescentials.com; instagram.com/ravenscroftoils
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/12/2021
"ELEVATION OF MIND AROMAMIST”
Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
351 NW Pleasant View Dr, Grants Pass OR 37526
ravenscroftescentials.com; instagram.com/ravenscroftoils
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/12/2021
“HEALER’s CHAI AROMATEA & BREATH DROPS”
Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
351 NW Pleasant View Dr, Grants Pass OR 37526
ravenscroftescentials.com; instagram.com/ravenscroftoils
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/12/2021
“AIR PURIFY AROMAMIST”
Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials
351 NW Pleasant View Dr, Grants Pass OR 37526
ravenscroftescentials.com; instagram.com/ravenscroftoils
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/05/2021
2 Own The Knight Silver 4000
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/05/2021
Rhino SE7EN2
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/05/2021
Stiff Rox
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/05/2021
Titanium 18K
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
03/05/2021
"IoWipe," Hand wipe product
CAMA Wellness Center/IodoRios Company, LLC
6782 Germantown Ave. Philadelphia, PA 19119
cp.camacenter.com; facebook.com/IoWipe
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/01/2021
"Balance CBD Drops"
Cannafyl
7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
03/01/2021
"Relief CBD Drops"
Cannafyl
7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
03/01/2021
"Relax CBD Drops"
Cannafyl
7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
03/01/2021
"Relief CBD Salve"
Cannafyl
7595 E. McDonald Dr., Suite 140, Scottsdale, AZ 85250
cannafly.com; facebook.com/cannafyl; twitter.com/cannafyl; instagram.com/cannafylcbd/
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
03/01/2021
“Immunoral”
Ageless Global, LLC
2722 S. West Temple, Salt Lake City, UT 84115
agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/01/2021
“Immune Plus”
Ageless Global, LLC
2722 S. West Temple, Salt Lake City, UT 84115
agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/01/2021
“MD Immune Support Spray”
Ageless Global, LLC
2722 S. West Temple, Salt Lake City, UT 84115
agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
03/01/2021
“MD CVK-365 Mouth Spray”
Ageless Global, LLC
2722 S. West Temple, Salt Lake City, UT 84115
agelessgloballab.com; cvk365.com; covid19mdhub.com; lionsfuel.com; mdimmunespray.com; mdmouthspray.com; instagram.com/immunoralcvk365; instagram.com/ageless_global_/; facebook.com/Ageless-Global-101773438401247; twitter.com/Ageless_Global/; linkedin.com/company/ageless-global/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
02/26/2021
Vy & Tea
Qikmoov, LLC
n/a
vyteaus.com
Undeclared sibutramine
Public Notification
Drugs
02/26/2021
“LUNGENE [sic] SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette to Detect Previous Corona Virus Infections”
Orvic dba Webstore-USA
15922 Strathern St #16, Van Nuys, CA 91406
facemaskandppestore.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
02/24/2021
Alpha Male Plus (also referred to as Alpha Male+)
Various Distributors
n/a
alphamaleplus.us
Undelclared tadalafil
Public Notification
Drugs
02/18/2021
MindSoothe Drops
Native Remedies dba Silver Star Brands
250 City Center, Oshkosh, WI 54906
nativeremedies.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
MindSoothe Capsules
Native Remedies dba Silver Star Brands
250 City Center, Oshkosh, WI 54906
nativeremedies.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Mood Support
Mountain Peak Nutritionals
9953 SW Arctic Dr., Beaverton, OR 97005
mountainpeaknutritionals.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Natural Anxiety & Depression Relief
Wholesome Wellness
6804 NE 79th Court, Portland, OR 97218
wholesome-wellness.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Mood Boosting Probiotic
Lifted Naturals
1101 Mulberry St, A2 Suite 10, Kansas City, MO 64101
liftednaturals.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
“Enlifta Mood Elevator”
Enlifta, LLC
16372 Page St., Omaha, NE 68118
enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
“Enlifta Anxiety”
Enlifta, LLC
16372 Page St., Omaha, NE 68118
enlifta.com; amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
St. John’s Wort
Blossom Nature, LLC
1193 Elederberry Circle, Folsom, CA 95630
blossom-nature.com; amazon.com/Supplement-National-Antidepressant-Support-Provides-Relief-120/dp/B082TTLJGP
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Full Spectrum™ St. John's Wort Extract
ProHealth Inc.
555 Maple St, Carpinteria, CA 93013
prohealth.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Dr. Garber's Depression Relief
Dr. Garber’s Natural Solutions
2607 2nd St #1, Santa Monica, CA 90405
drgarbers.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Inositol 100% Pure Free Form
FDC Nutrition Inc.
2313 East Philadelphia Street Ste L, Ontario, CA
fdcnutrition.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Sleep Sana “Sleep Drops”
SANA Group LLC
1200 E. Woodhurst S-200, Springfield, MO 65804
sleepsana.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
Sleep Sana “Sleep Shots”
SANA Group LLC
1200 E. Woodhurst S-200, Springfield, MO 65804
sleepsana.com
New Drug/Misbranded
Warning Letter
Foods
News Release
02/18/2021
“Liposomal Vitamin C”
Mercola.com, LLC
125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
mercola.com; mercolamarket.com; twitter.com/mercola
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
02/18/2021
“Liposomal Vitamin D3”
Mercola.com, LLC
125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
mercola.com; mercolamarket.com; twitter.com/mercola
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
02/18/2021
“Quercetin and Pterostilbene Advanced”
Mercola.com, LLC
125 SW 3rd Place, Suite 205, Cape Coral, FL 33991
mercola.com; mercolamarket.com; twitter.com/mercola
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
02/18/2021
Earth Tea Extra Strength
B4B Corp.
40 Remsen Ave, Brooklyn, NY 11212
b4bcorp.com; twitter.com/b4bcorpusa
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
02/18/2021
The Prevention 12 Pak (Coronavirus Prevention 12 Pak), consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine)
SafaLab, Inc.
317 Cascade Ave., Langley, WA 98260
safalab.com; weeksmd.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
02/16/2021
“COVID-Aid Tincture”
Dr. Paul's Lab
9559 County Road Y, Mazomanie, WI 53560
drpaulslab.net; drsarahsessentials.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
02/11/2021
“BioCBD+ Total Body Care”
Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
02/11/2021
“BioCBD+ Topical Oil Muscle & Joint Support”
Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
02/11/2021
“BioCBD+ Peace Vape”
Evolved Ayurvedic Discoveries, Inc./BioCBDPlus
315 S. Coast Highway 101 Suite U75, Encinitas, CA 92024
biocbdplus.com; facebook.com/BioCBDPlus; instagram.com/bio_cbd_plus
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
02/02/2021
“OsteoBLAST®”
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141, Webster, TX 77598
clarkepharmaceuticals.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
02/02/2021
“Cell Block #19”
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141, Webster, TX 77598
clarkepharmaceuticals.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
02/02/2021
“High Potency Vitamin D3”
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141, Webster, TX 77598
clarkepharmaceuticals.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
02/02/2021
“Neupanex®”
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141, Webster, TX 77598
clarkepharmaceuticals.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
02/02/2021
“Natural Progesterone Skin Cream”
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141, Webster, TX 77598
clarkepharmaceuticals.com
Unapproved New Drugs/Misbranded
Warning Letter
Drugs
01/25/2021
“COVID-19 BLOOD SPOT COLLECTION PACKET”
EnMed MicroAnalytics, Inc.
645 Meeting St, Suite 2, Charleston, SC 29403-4279
enmedmicroanalytics.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
01/25/2021
“SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET"
EnMed MicroAnalytics, Inc.
645 Meeting St, Suite 2, Charleston, SC 29403-4279
enmedmicroanalytics.com
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Devices
01/22/2021
AloeCure VeraFlex
American Global Health Group, LLC
11808 Northup Way, Suite W105, Bellevue, WA 98005
aloecure.com; facebook.com/aloecure
New Drug/Misbranded
Warning Letter
Foods
01/22/2021
AloeCure Advanced Formula Capsule
American Global Health Group, LLC
11808 Northup Way, Suite W105, Bellevue, WA 98005
aloecure.com; facebook.com/aloecure
New Drug/Misbranded
Warning Letter
Foods
01/22/2021
AloeCure Pure Aloe Vera Extract
American Global Health Group, LLC
11808 Northup Way, Suite W105, Bellevue, WA 98005
aloecure.com; facebook.com/aloecure
New Drug/Misbranded
Warning Letter
Foods
01/22/2021
AloeCure Probiotic + Enzyme
American Global Health Group, LLC
11808 Northup Way, Suite W105, Bellevue, WA 98005
aloecure.com; facebook.com/aloecure
New Drug/Misbranded
Warning Letter
Foods
01/19/2021
Adam’s Secret Extra Strength 1500
Various Distributors
n/a
adamssecret.co; walmart.com
Undeclared tadalafil and sildenafil
Public Notification
Drugs
Recall
01/19/2021
Adam’s Secret Extra Strength 3000 Platinum
Various Distributors
n/a
adamssecret.co
Undeclared tadalafil and sildenafil
Public Notification
Drugs
Recall
01/14/2021
“Golden Milk Electuary-Mushroom Cocoa Blend”
Sage Moon Apothecary LLC
40 Main Street, Seal Harbor, ME 04675
sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
New Drug/Misbranded
Warning Letter
Foods
Closeout Letter
01/14/2021
“Golden Milk Electuary”
Sage Moon Apothecary LLC
40 Main Street, Seal Harbor, ME 04675
sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
New Drug/Misbranded
Warning Letter
Foods
Closeout Letter
01/14/2021
“Beyond Elderberry Syrup”
Sage Moon Apothecary LLC
40 Main Street, Seal Harbor, ME 04675
sagemoonapothecary.net; etsy.com/shop/SageMoonApothecary; facebook.com/sagemoonapothecarymaine
New Drug/Misbranded
Warning Letter
Foods
Closeout Letter
01/12/2021
Allicin capsules
Allimax Us
500 W Superior St Unit 2205, Chicago, IL 60654
allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/12/2021
Allicin creams
Allimax Us
500 W Superior St Unit 2205, Chicago, IL 60654
allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/12/2021
Allicin gels
Allimax Us
500 W Superior St Unit 2205, Chicago, IL 60654
allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/12/2021
Allicin sprays
Allimax Us
500 W Superior St Unit 2205, Chicago, IL 60654
allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/12/2021
Allicin liquid products
Allimax Us
500 W Superior St Unit 2205, Chicago, IL 60654
allimax.us; facebook.com/allimaxUS/; instagram.com/allimaxusa/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/12/2021
“Corona Destroyer Tea”
AusarHerbs
201 S. D Street, Madera, CA 93639
ausarherbs.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
01/06/2021
Lion's Mane -All Natural Supplement
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/06/2021
Antrodia Mushroom Powder
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/06/2021
Maitake Mushroom Powder
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/06/2021
Reishi Mushroom Powder
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/06/2021
Cordyceps Mushroom Powder
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/06/2021
Cordyceps - All Natural Mushroom Dietary Supplement
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800, Sherwood, OR 97140
totalnutraceutical.com
New Drug/Misbranded
Warning Letter
Foods
01/04/2021
4-Thieves Florida Tea Concentrate
Coco's Holistic Specialties & Apothecary
n/a
cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
01/04/2021
4-Thieves Florida Tea Powder
Coco's Holistic Specialties & Apothecary
n/a
cocosholisticspecialties.org/; facebook.com/KaliLengua; twitter.com/CocoEtsy
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/28/2020
Smarter Curcumin
Smarter Nutrition, Inc.
17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
smarternutrition.com; facebook.com/smarternutrition1
New Drug/Misbranded
Warning Letter
Foods
12/28/2020
Smarter Ubiquinol
Smarter Nutrition, Inc.
17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
smarternutrition.com; facebook.com/smarternutrition1
New Drug/Misbranded
Warning Letter
Foods
12/28/2020
Smarter Vitamin D3
Smarter Nutrition, Inc.
17870 Newhope St. Suite 104-480, Fountain Valley, CA 92708
smarternutrition.com; facebook.com/smarternutrition1
New Drug/Misbranded
Warning Letter
Foods
12/22/2020
Synotrex
Speedwinds Nutrition, Inc.
818 SW 3rd Avenue, Portland, OR 97204
speedwindsnutrition.com; synotrex.com; amazon.com
New Drug/Misbranded
Warning Letter
Foods
12/22/2020
Sephren
Speedwinds Nutrition, Inc.
818 SW 3rd Avenue, Portland, OR 97204
speedwindsnutrition.com; synotrex.com; amazon.com
New Drug/Misbranded
Warning Letter
Foods
12/22/2020
RHINODOL CBD” nasal spray products
New Leaf Pharmaceuticals, LLC
77 South Main Street, Newton, CT 06470
newleafpharma.com; facebook/CBDMedicalProducts/
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Warning Letter
Drugs
12/22/2020
Various human and animal products, promoted to contain cannabidiol (CBD)
NextL3vel Services Group, LLC dba This Stuff Is Good For You
3400 W. Desert Inn Rd. Suite 2, Las Vegas, NV 89102
thisstuffisgoodforyou.com; facebook.com/tsigfy; instagram.com/tsigfy
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs; Animal & Veterinary
12/22/2020
“WBRx Metered-Dose Inhaler"
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
"WBRx Balance Softgels CBD”
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
“WBRx Pure Wellness CBD” (“WBRx Combo Pack”)
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
“WBRx Energy Oil Drops CBD”
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
“WBRx Relief Balm CBD”
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
“WBRx Sleep Oil Drops CBD
Wellness BioSciences Rx
9789 Katy Freeway #1801, Houston, TX 77024
wbrxglobal.com; twitter.com/wellnessbiosrx
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Warning Letter
Drugs
12/22/2020
“Canna Bees Rescue Blend”
Bee Delightful
n/a
beedelightful.com; facebook.com/BeeDelightfulUSA
Unapproved New Drugs/Misbranded
Warning Letter
Foods
12/21/2020
“C BETTER DAILY Adult Regular Formula”
G & L Wellness, LLC
2231 14th St S 114, Wisconsin Rapids, WI 54494
glwellness.net
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Warning Letter
Drugs; Animal & Veterinary
12/21/2020
“C BETTER DAILY Adult Maximum Formula”
G & L Wellness, LLC
2231 14th St S 114, Wisconsin Rapids, WI 54494
glwellness.net
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Warning Letter
Drugs; Animal & Veterinary
12/21/2020
“C BETTER DAILY Soothing Formula”
G & L Wellness, LLC
2231 14th St S 114, Wisconsin Rapids, WI 54494
glwellness.net
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Warning Letter
Drugs; Animal & Veterinary
12/21/2020
“Flu Immune Drops”
Riverstone LLC
51668 Blue River Dr, Blue River, OR 97413
doctorschoice.org
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
“L-Lysine”
Riverstone LLC
51668 Blue River Dr, Blue River, OR 97413
doctorschoice.org
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
“Lysine Extra”
Riverstone LLC
51668 Blue River Dr, Blue River, OR 97413
doctorschoice.org
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
“Monolaurin”
Riverstone LLC
51668 Blue River Dr, Blue River, OR 97413
doctorschoice.org
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
Organic Liposomal Vitamin C
Sparrow Health & Performance LLC
2000 Southlake Park Suite 150, Hoover, AL 35244
sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
Nanoemulsified D3K2 (also referred to as “Liquid Liposomal Vitamin D3 with K2” or “Liposomal Vitamin D3”
Sparrow Health & Performance LLC
2000 Southlake Park Suite 150, Hoover, AL 35244
sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/21/2020
Immune Support Package (which includes your Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Virus Be Gone products, with Smart Silver as an optional add-on)
Sparrow Health & Performance LLC
2000 Southlake Park Suite 150, Hoover, AL 35244
sparrowclinic.com; facebook.com/sparrowclinic; instagram.com/sparrowclinic/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/18/2020
“Glycostasis”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Glucosamine Curcumin”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Turmeric 50”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Turmeric Curcumin”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Cetyl Curcumin”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Ashwagandha”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Huruli”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Black Seed Oil”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Curcumin Turmerone”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
“Ashwagandha Honey”
Reddy Naturals
1300 Cobb International Dr. NW Suite A, Kennesaw, GA 30152
reddynaturals.com; facebook.com/ReddyNaturals
New Drug/Misbranded
Warning Letter
Drugs
12/18/2020
CloSYS Non-Irritating RINSE Mildly Flavored for SENSITIVE Mouths
Rowpar Pharmaceuticals
16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
closys.com; facebook.com/ClosSYS; twitter.com/closys
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/18/2020
CloSYS Oral Spray
Rowpar Pharmaceuticals
16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
closys.com; facebook.com/ClosSYS; twitter.com/closys
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/18/2020
CloSYS Non-Irritating RINSE UN-flavored for ULTRA SENSITIVE Mouths
Rowpar Pharmaceuticals
16100 N. Greenway Hayden Loop #400, Scottsdale, AZ 85260
closys.com; facebook.com/ClosSYS; twitter.com/closys
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/17/2020
Triple SupremeZen Plus 3500
Various Distributors; Recall by Yolo Studio/Hyobin LLC
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Shogun-X Black
Various Distributors; Recall by Ummzy LLC/Knabe Inc
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Triple SupremeZen Extreme 3500
Various Distributors; including seller Otwo
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Thumbs Up 7 White 11K
Various Distributors; Recall by Nuri Trading LLC
n/a
amazon.com
Undeclared sildenafil, tadalafil and vardenafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Thumbs Up 7 Red 70K
Various Distributors; Recalls by Antoto-K and Ummzy LLC/Knabe Inc
n/a
amazon.com
Undeclared sildenafil, tadalafil and vardenafil
Public Notification
Drugs
News Release
Recall (Antoto-K)
Recall (Ummzy LLC/Knabe Inc)
Untitled Letter
12/17/2020
Thumbs Up 7 Blue 69K
Various Distributors; Recall by Bit & Bet LLC
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Thumbs Up 7 Black 25K
Various Distributors; Recall by Nuri Trading LLC
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Rock Steady 72 Hours
Various Distributors; including seller Rock Steady 72 Hours
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Red Spartan 3000
Various Distributors; including seller Amazon.com
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Premium OrgaZen 7000
Various Distributors; Recall by NS NY Distributor Inc
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Premier Platinum 5000 (PremierZEN Platinum 5000)
Various Distributors; Recall by NANA Collection LLC/E-Factory NY
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
PremierZen Extreme 3000
Various Distributors; Recalls by QMART and Yolo Studio
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall (QMART)
Recall (Yolo Studio)
Untitled Letter
12/17/2020
PremierZen Black 5000
Various Distributors; Recall by Namoo Enterprise LLC/All-R0under
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Original White Dragon
Various Distributors; including seller A&D Health
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Krazy Night
Various Distributors; Recall by Ummzy LLC/Knabe Inc
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Kopi Jantan Tradisional Natural Herbs Coffee
Various Distributors; including seller smile_elephant
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Imperial Platinum 2000
Various Distributors; Recall by QMART
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Imperial Gold 2000
Various Distributors; Recall by QMART
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Imperial Extreme 2000
Various Distributors; Recall by S&B Shopper LLC
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Hot Rod
Various Distributors; including BZ USA LLC/BZ USA LLC
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Ginseng Power 5000
Various Distributors; Recall by NS NY Distributor Inc
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Burro en Primavera 60000
Various Distributors; Recall by QMART
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
69MODE Blue 69
Various Distributors; Recall by Nuri Trading LLC
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
3 KO Gold XT
Various Distributors; including seller Vitality Mate
n/a
amazon.com
Undeclared vardenafil
Public Notification
Drugs
News Release
Untitled Letter
12/17/2020
Shogun-X Platinum 7000
Various Distributors; Recall by Nuri Trading LLC
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Triple SupremeZen Gold 3500
Various Distributors; Recall by NANA Collection LLC/E-Factory NY
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
Untitled Letter
12/17/2020
Burn 7
Various Distributors; including seller befitaholic
n/a
ebay.com
Undeclared phenolphthalein
Public Notification
Drugs
News Release
12/17/2020
Premier maxxzen Platinum 12000
Various Distributors; including seller Miracle8989
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
12/17/2020
Poseidon Platinum 10000
Various Distributors; including seller co.america
n/a
ebay.com
Undeclared vardenafil
Public Notification
Drugs
News Release
12/17/2020
Poseidon Platinum 3500
Various Distributors; including seller Yamtun7
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
12/17/2020
Mero Macho
Various Distributors; including seller setec24
n/a
ebay.com
Undeclared tadalafil
Public Notification
Drugs
News Release
12/17/2020
Gold Lion
Various Distributors; including seller unityhealth
n/a
ebay.com
Undeclared sildenafil
Public Notification
Drugs
News Release
12/17/2020
White Panther
Various Distributors; including seller qualmart1-9
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
12/17/2020
Triple Wicked Platinum
Various Distributors; including seller pricemasters_usa
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
12/17/2020
The Super Panther 77k
Various Distributors; including seller qualmart1-9
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
12/17/2020
Royal Honey
Various Distributors; including seller ahmedjamilmuslim
n/a
ebay.com
Undeclared tadalafil
Public Notification
Drugs
News Release
12/17/2020
PremierZen Gold 7000
Various Distributors; Recall by Miracle8989
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
12/17/2020
PremierZen Platinum 8000
Various Distributors; Recall by Miracle8989
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
Recall
12/17/2020
Blue Panther Extreme 75k
Various Distributors; including seller qualmart1-9
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
News Release
12/17/2020
Black Stallion 9000
Various Distributors; including seller qualmart1-9
n/a
ebay.com
Undeclared tadalafil
Public Notification
Drugs
News Release
12/17/2020
Lishou Slimming Coffee
Various Distributors; including seller annday14
n/a
ebay.com
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
News Release
12/17/2020
Li Da Daidaihua Plus
Various Distributors; including seller micki_jay
n/a
ebay.com
Undeclared phenolphthalein
Public Notification
Drugs
News Release
12/17/2020
Imperla Elita Vitaccino
Various Distributors; Recall by Dash Xclusive
n/a
ebay.com
Undeclared sibutramine and fluoxetine
Public Notification
Drugs
News Release
Recall
12/17/2020
Fruta Planta
Various Distributors; including seller aialoj0
n/a
ebay.com
Undeclared sibutramine
Public Notification
Drugs
News Release
12/17/2020
Fruta Bio
Various Distributors; including seller frutabio
n/a
ebay.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
News Release
12/17/2020
Super Slim
Various Distributors; including seller emmcli0
n/a
ebay.com
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
News Release
12/15/2020
“Oleander 4X”
Phoenix Biotechnology, Inc.; Avila Herbals, LLC
8626 Tesoro Dr., Suite 801, San Antonio, TX 78217 4025 Childress Rd., Christiansburg, VA 24073
phoenixbiotechnology.com; myoleander.com; avilaherbals.com; twitter.com/PhoenixBioInc
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Drugs
12/10/2020
"Chest Tea”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Ginger Oil”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Dandelion root Tincture”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Echinacea purpurea Tincture”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Antispasmodic Tincture”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Ginger Tincture”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
“Cayenne Tincture”
Prairie Dawn Herbs
4250 S. Calhan Hwy Yoder, CO 80864-9669
prairiedawnherbs.com
Finished Pharmaceuticals/Unapproved new drug
Warning Letter
Foods
12/10/2020
Vitamins
iThrive.health
n/a
ithrive.health; facebook.com/iTHRIVE.health/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/10/2020
Quercetin products
iThrive.health
n/a
ithrive.health; facebook.com/iTHRIVE.health/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/10/2020
Zinc products
iThrive.health
n/a
ithrive.health; facebook.com/iTHRIVE.health/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/10/2020
Omega-3 products
iThrive.health
n/a
ithrive.health; facebook.com/iTHRIVE.health/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/10/2020
Mineral products
Indigenous Products
Dallas, TX 75232
facebook.com/Indigenous-Products-106070747498475/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/09/2020
Healthy-Thin Energize”
Bodyhealth.com, LLC
707 Cleveland St. Clearwater, FL 33755-4107
bodyhealth.com
New Drug/Misbranded
Warning Letter
Foods
12/09/2020
“Body Detox (Oral Spray)”
Bodyhealth.com, LLC
707 Cleveland St. Clearwater, FL 33755-4107
bodyhealth.com
New Drug/Misbranded
Warning Letter
Foods
12/09/2020
“Omega 3 Health”
Bodyhealth.com, LLC
707 Cleveland St. Clearwater, FL 33755-4107
bodyhealth.com
New Drug/Misbranded
Warning Letter
Foods
12/07/2020
“Thymosin Alpha 1”
Paradigm RE LLC
1511 N. Convent 700-156 Bourbonnais, IL 60914
paradigmpeptides.com/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/04/2020
Fortify
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Lion's Mane
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
The Great Work
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Mind Ease
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Sweet Balance
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Happy Heart
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Flair Snare
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/04/2020
Cordycepts sinensis double extract
Desert Alchemist LLC
Tucson, AZ
etsy.com/shop/DesertAlchemis; facebook.com/desertalchemist; instagram.com/desert
New Drug/Misbranded
Warning Letter
Foods
12/02/2020
“Evening Primrose Oil”
Smoky Mountain Naturals, LLC
3605 Nebraska Avenue Nashville, TN 37209
smnutrition.com
New Drug/Misbranded
Warning Letter
Foods
12/02/2020
“Beta Glucan"
Smoky Mountain Naturals, LLC
3605 Nebraska Avenue Nashville, TN 37209
smnutrition.com
New Drug/Misbranded
Warning Letter
Foods
12/02/2020
C60 (Carbon 60), including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION”
Heavenly Natural Products
100 Monroe St #406 Centerton, AR 72719
heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/02/2020
Colloidal silver, including "Heavenly Silver"
Heavenly Natural Products
100 Monroe St #406 Centerton, AR 72719
heavenlynaturalproducts.com; facebook.com/heavenlyc60; twitter.com/hnpC60; pinterest.com/heavenlynaturalproductsc/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/02/2020
“VIRUS BIOSHIELD”
Rat's Army
4126 US HWY 93 S Kalispell, MT 59901
rats.army/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
12/02/2020
"Dr. Hotze’s Immune Pak with Vitamins A, B, C, D, Zinc and Probiotics”
Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
20214 Braidwood, Ste. 215 Katy, TX 77450
hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/02/2020
“Dr. Hotze’s Kids Immune Pak”
Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
20214 Braidwood, Ste. 215 Katy, TX 77450
hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
12/02/2020
“Dr. Hotze’s Teen Immune Pak”
Health & Wellness Center International One, L.L.C. dba Hotze Vitamins
20214 Braidwood, Ste. 215 Katy, TX 77450
hotzehwc.com; hotzevitamins.com; facebook.com/Hotze-HWC/; facebook.com/MyHotzeVitamins/ twitter.com/hotzehealth.com; twitter.com/HotzeVitamins/
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
11/24/2020
U.S.A. Viagra
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Stree Overlord
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil and ciprofloxacin
Public Notification
Drugs
11/24/2020
Rhinozen 69 Platinum 75000
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Rhino 99 Extreme 90000
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Rhino 96 Platinum 77000
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Rhino 69 Platinum 25000
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Rhino 69 Power 500K
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Rhino 8 Platinum 80000
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Body Shape Weight Loss System
Various Distributors
n/a
Examination of imported goods
Undeclared sibutramine
Public Notification
Drugs
11/24/2020
Bigger Longer More Time More Sperms (sic)
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Herb Viagra Male Sexual Stimulant
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Magnum XXL 50K
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
Magnum XXL 9800
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/24/2020
V8 Super Energy
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/18/2020
Vigorous Man
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/18/2020
Livtone
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and fluoxetine
Public Notification
Drugs
09/01/2020
Red-E
The Protein Shoppe, LLC
101 E Exp. 83 Ste. A-1 Pharr, TX 78557
The Protein Shoppe, LLC
Undeclared sildenafil
Recall
Drugs
07/09/2020
Tenadam Herb
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Spiced Tea
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Nigerian Moringa Leaf Powder
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Jamaican Turmeric
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Bitter Wood
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Devil Horsewhip
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Mango Leaf
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Red Water Grass
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Sarsaparilla
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Marsh Marigold
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Sea Moss/Irish Moss
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Dog Blood
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Guava Leaf
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Jack in the Bush
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
King of the Forest
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
ETHIOPIAN ABISH (FENNUGREEK SEED PWD.)
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Ethiopian Traditional Talba (Flaxseed Meal Cereal)
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Fever Grass
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Jamaican Milk Wiss
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Spanish Needle
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Fig Leaf
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Diabetics
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Flax Seed Oil & Honey Blend
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Bitter Kola (Arogbo)
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Jamaican Bissy Powder
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Ghanian Black Spice
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Piss A Bed
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
White Pond Lily
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Purple Sage
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Quassia Wood
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Trumpet Leaf
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
White Jointa
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
White Sage
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Guinea Hen Weed
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Sundial Cassava Meal
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Cocoa Balls
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
African Fever Bush
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Mojo Bush
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Blood Leaf
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Wood & Root Tonic
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Koromantee
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Ashanti
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
African Manback Tonic
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Pimento
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Mitmitta (Cayenne Pepper)
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Mahogany Bark
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Chaney Root
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Cerasee Bay Leaves, Mango Bark
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Asthma
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Blood Pressure
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Heart
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Worms and Parasites
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Flu-Allergies /HayFever
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Arthritis
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Axum Traditional Ethiopian Honey Beverage
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Black Sage
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Black Wiss
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Cinnamon
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Palo De Brazil
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Broom Weed
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Bread Nut
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Jamaican and Tropical Raw Honey
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Hemp Seed Oil
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Talibah’s Tooth Powder and Ethiopian Coffee
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
07/09/2020
Blue Vervain
Sundial Herbal Products
3609 Boston Road, Bronx, NY
sundialherbs.com/sundial
Misbranding & Unapproved New Drugs
Recall
Foods
05/20/2020
Sterile Cannabidiol (CBD) previously listed as Cannabidiol (CBD) Complex
Biota Biosciences, LLC
Seattle, WA
n/a
Unapproved new drug; injectable products marketed without FDA approval
Recall
Drugs
05/20/2020
Sterile Curcumin previously listed as Curcumin Complex 4 10 mL
Biota Biosciences, LLC
Seattle, WA
n/a
Unapproved new drug; injectable products marketed without FDA approval
Recall
Drugs
05/20/2020
Sterile Cannabidiol (CBD) + Curcumin previously listed as Cannabidiol (CBD) + Curcumin Complex
Biota Biosciences, LLC
Seattle, WA
n/a
Unapproved new drug; injectable products marketed without FDA approval
Recall
Drugs
05/19/2020
Dr. Rima RecommendsTM Nano Silver 10 PPM
Natural Solutions Foundation
58 Plotts Rd, Newton NJ 07860
drrimatruthreports.com; opensourcetruth.com; truthaboutcoronavirus.com; nsfmarketplace.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Foods
Recall
05/11/2020
“CORE”
Fusion Health and Vitality LLC
1360 Union Hill Road Suite 11B, Alpharetta, GA 30004
pharmorigins.com; freecoreoffer.online; immune-shot.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
Recall
05/11/2020
“IMMUNE SHOT”
Fusion Health and Vitality LLC
1360 Union Hill Road Suite 11B, Alpharetta, GA 30004
pharmorigins.com; freecoreoffer.online; immune-shot.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
Recall
05/06/2020
NAD+ Sublingual Gel
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
05/06/2020
NMN Sublingual Gel
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Warning Letter
Drugs
04/22/2020
Black Mamba Premium 18000
Bandera Ice House
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
03/16/2020
Active Male
Natural Remedy Store
San Antonio, TX
Natural Remedy Store
Undeclared tadalafil
Recall
Drugs
02/24/2020
Bow & Arrow
Med Man Distribution
n/a
Distributed in the USA to Regal Labs and to their nationwide retailers
Undeclared sildenafil
Recall
Drugs
02/05/2020
XXX Platinum WOODIE
Various Distributors
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
02/05/2020
Alpha-Male
Various Distributors
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
02/05/2020
RMFLEX
Various Distributors
n/a
ebay.com
Undeclared diclofenac
Public Notification
Drugs
02/05/2020
OrgaZEN Gold 5800
Various Distributors
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
12/18/2019
U-Dream Lite
Various Distributors
n/a
amazon.com
Undeclared eszopiclone and zopiclone
Public Notification
Drugs
12/18/2019
U-Dream Full Night
Various Distributors
n/a
amazon.com
Undeclared eszopiclone and zopiclone
Public Notification
Drugs
12/17/2019
SUPER Platinum 30000 RHINO 7
Motto International Corp.
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/17/2019
SUPER Platinum 30000 PANTHER
Motto International Corp.
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/17/2019
SUPER Platinum 30000 STALLION
Motto International Corp.
n/a
n/a
Undeclared sildenafil, tadalafil, and dapoxetine
Public Notification
Drugs
12/17/2019
SUPER Platinum 30000 BULL
Motto International Corp.
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/13/2019
PremierZEN Gold 7000
Various Distributors
n/a
voltcandyonline.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/09/2019
Essential Oils, including Bergamot bergaptene free (Citrus bergamia), Listea Cubea, Cypress – Cupressus sempervirens, Cinnamon Leaf – Cinnamomum zeylanicum, Chamomile Roman – Anthemis nobilis, and Carrot Seed – Daucus carota
Kelley Pure Essentials Oils
404 W. 5th St. New Richmond, WI 54017
kelleypureessentialoils.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/09/2019
Herbal Detox Pearls
Coochie Couture
P.O. Box 251 Selden, NY 11784
coochiecouture.net/; instagram.com/coochiecouture_/; facebook.com/coochiecouturee
New Drugs
Online Advisory Letter
Foods; Drugs
12/09/2019
Blood Sugar Ultra
Blood Sugar Ultra
1140 S. Highbrook Street Suite 400 Akron, OH 44301
healthtech24.net/diabetes-report; bloodsugarultra.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/09/2019
SNAP Capsule Formula
Simply Natural Advanced Pharma (SNAP)
n/a
adhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHD
New Drugs
Online Advisory Letter
Foods; Drugs
12/09/2019
SNAP Liquid Formula
Simply Natural Advanced Pharma (SNAP)
n/a
adhdsnap.com; facebook.com/SNAPtoday/; instagram.com/snap4health/; twitter.com/SNAP4ADHD
New Drugs
Online Advisory Letter
Foods; Drugs
12/04/2019
Detox Plus
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil, paynantheine, and mitragynine
Public Notification
Drugs
11/14/2019
Power Khan
Various Distributors
n/a
powerkhanusa.com
Undeclared desmethyl thiosildenafil, thioaildenafil, and aildenafil
Public Notification
Drugs
11/13/2019
Man Erect
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/13/2019
SHENGDA
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/06/2019
Sheaya Lender
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and fluoxetine
Public Notification
Drugs
10/24/2019
CholesLo
HFL Solutions LLC
13077 Bluff Creek Dr., Playa Vista, CA 90094
choleslo.com
Undeclared lovastatin
Public Notification
Drugs
Warning Letter
10/17/2019
Skinny Pill
Lose Fat Gain Life M&B
4102 Orange Ave Ste 118 & 119, Long Beach, CA 90807
losefatgainlifemb.com
Undeclared 1,3-dimethylamylamine (DMAA)
Public Notification
Foods
Warning Letter
10/16/2019
UP2
Various Distributors
n/a
hmherbs.com
Undeclared sildenafil
Public Notification
Drugs
Recall
10/09/2019
CHU
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
09/26/2019
Kim Whitening Pearl and Snowlotus Cream
Kim Co, LTD
888/32 Bang Pree Industrial Estate , Samut Prakan, Samut Prakan Thailand
n/a
Found to contain 0.047 g/kg of mercury
Alert
Drugs
Import Alert 53-18
09/26/2019
Golden Pearl Beauty Cream
Golden Pearl Cosmetics
115/1 M , Quaid-e-Azam Industrial Estate , Kot Lakhpat, Lahore, Punjab Pakistan
n/a
Foods
Alert
Drugs
Import Alert 53-18
09/26/2019
Chandni Whitening Cream
SJ Enterprises
222 CCA FF , DHA Phase 4 Sector CCA , Lahore, Punjab Pakistan
n/a
Found to contain 8.79 g/kg of mercury
Alert
Drugs
Import Alert 53-18
09/26/2019
Goree Beauty Cream
Goree Cosmetics
n/a
n/a
Found to contain 17.2 g/kg of mercury
Alert
Drugs
09/26/2019
Sandal Whitening Beauty Cream
MMC Cosmetics Pakistan
Main Bazar Rd , Karbirwala, Khanewal Pakistan
n/a
Found to contain 13.1 g/kg of mercury
Alert
Drugs
Import Alert 53-18
09/26/2019
Monespa Express Peeling
Various Distributors
n/a
n/a
Found to contain 5.03 g/kg of mercury
Alert
Drugs
09/26/2019
Face Fresh Beauty Cream
Shaheen Costmetics PVT LTD
House #8, Block-A4 , P.G.E.C.M.S Punjab Society , Lahore, Punjab Pakistan
n/a
Found to contain 18.5 g/kg of mercury
Alert
Drugs
Import Alert 53-18
09/19/2019
Green Lumber
GL Holdings
Newport Beach, California
getgreenlumber.com; greenlumber.com
Undeclared tadalafil
Public Notification
Drugs
Recall
09/16/2019
Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement
Fitoterapia USA Inc.
n/a
fitoterapiausa.com
Undeclared tadalafil
Recall
Drugs
09/09/2019
Anaconda Strong Formula
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/09/2019
La Pepa Negra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/09/2019
Lung Leader
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/06/2019
Lanugar
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
09/06/2019
JaDera PLUS
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, N-desmethylsibutramine, and benproperine
Public Notification
Drugs
09/06/2019
Love in S
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
09/06/2019
LOBO
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/06/2019
Mero Macho
Various Distributors
n/a
fitoterapiausa.com; meromachodrink.com
Undeclared tadalafil
Public Notification
Drugs
07/25/2019
Chrysanthemum/Hibiscus Blend Tea
Moyeam USA TEA, LLC
n/a
pureamitea.com; getmoyeam.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Eagle Tea
Moyeam USA TEA, LLC
n/a
pureamitea.com; getmoyeam.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Qing Yun Moyeam Tea
Moyeam USA TEA, LLC
n/a
pureamitea.com; getmoyeam.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
NAD+/H2S Energizer
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
NAD+ Defender
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Pure NAD+ Sublingual tablets
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Pure NAD+ Sublingual powder
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Liquid NAD+ Sublingual drops
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Pure NAD+ Nasal Spray,
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
NMNs Sublingual tablets (30 ct and 240 ct)
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Pure NMN Sublingual powder
Alive By Nature, Inc.
2574 Whispering Pines Dr. Fleming Island, FL 32003
alivebynature.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Pulverexx
Doctor Eden LLC
10030 NW 6th Terr. Miami, FL 33172
doctoreden.com; facebook.com/dredenhealth/; twitter.com/DrMEden; pinterest.com/drmarioeden
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
GF20 Plus Oral Spray
Leading Edge Health
100 Fidelitone Way Elizabethton, TN 37643
leadingedgehealth.com; genf20.com; gen20.com
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
GF20 Plus Capsules
Leading Edge Health
100 Fidelitone Way Elizabethton, TN 37643
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Moses Kit (Moses Cream + Moses Oil)
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
IQ+ Joy, Sleep, Anxiety
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Essential Eye Oil for Glaucoma
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Certified Organic Frankincense
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
High Blood Pressure Support
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Moses Lip Balm-Rose
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Moses Lip Balm-Natural
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Fix It All
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Moses Oils
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Moses Cream
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Clear Nose
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/25/2019
Hair Maximizer
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Food; Drugs
07/25/2019
Cancer Support (Big C Support)
Bible Healing Oils
111 5th Avenue East Buckeye, AZ 85326
biblehealingoils.net
Unapproved New Drugs
Online Advisory Letter
Foods; Drugs
07/22/2019
Bido CBD for Pets
Curaleaf, Inc.
301 Edgewater Place Suite 405, Wakefield, MA 01880
curaleafhemp.com
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2019
CBD Disposable Vape Pen
Curaleaf, Inc.
301 Edgewater Place Suite 405, Wakefield, MA 01880
curaleafhemp.com
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2019
CBD Tincture
Curaleaf, Inc.
301 Edgewater Place Suite 405, Wakefield, MA 01880
curaleafhemp.com
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2019
CBD Pain-Relief Patch
Curaleaf, Inc.
301 Edgewater Place Suite 405, Wakefield, MA 01880
curaleafhemp.com
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/22/2019
CBD Lotion
Curaleaf, Inc.
301 Edgewater Place Suite 405, Wakefield, MA 01880
curaleafhemp.com
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Warning Letter
Drugs
07/16/2019
Reduktis Max
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
07/16/2019
Black Storm
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Big Penis
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Boss Lion 9000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
De Guo Heijin Gang
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Herb Viagra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
La Pepa Negra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Odimafo Powerful Tablet 200 mg
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Plant Vigra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Shengjingpian
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2019
Vigour 800 mg
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/01/2019
Lipro Dietary Capsule
Various Distributors
n/a
liprodietpill.com
Undeclared tadalafil
Public Notification
Drugs
06/26/2019
Adelgasin Plus
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethyl sibutramine
Public Notification
Drugs
06/26/2019
Super Slimming Herb
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
06/26/2019
Lishou Fuling Jiaonang
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethyl sibutramine
Public Notification
Drugs
06/26/2019
Detoxi Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
06/26/2019
Absolute Nine Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethyl sibutramine
Public Notification
Drugs
06/26/2019
Peru Maca
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/26/2019
Germany Black Gorilla
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/25/2019
12 Gram Kratom Powder Samples
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Borneo yellow Vein Kratom
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Bali Kratom Powder
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Cali's Best Premium Powder Mix
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Cali's Premium Special Reserve Kratom Powder
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Enhanced Maeng Da Capsules
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Green Malay Kratom Caps
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Kratom Capsule Samples
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Full Spectrum 50x Kratom Tincture
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Super Enhanced Bali Kratom
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/25/2019
Super Enhanced Maeng Da Kratom
Cali Botanicals, LLC
500 Sibley Street, Folsom, CA 95630
calibotanicals.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
06/23/2020
Anti-Viral Immune Enhancement Capsules
Golden Nutrition Inc.
Opa Locka, FL
goldennutrition.com
Unsubstantiated Health Claims on Label
Recall
Foods
06/06/2019
SpiroNIL
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
General Formula
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
Black Walnut
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
Alfalfa Herbal Tonic
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
Kidney Formula #1
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
Kidney Formula #2
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
06/06/2019
MicroNIL
PRL, Inc.
84 West Fourth Avenue, Lobelville, TN 37097-3267
forestcenterherbs.com
CGMP/Dietary Supplement/Adulterated/Misbranded
Warning Letter
Foods
05/22/2019
Man Fuel Xtreme Edition
Various Distributors
n/a
gomanfuel.com
Undeclared sildenafil, dithiodesmethyl carbodenafil and desmethyl carbodenafil
Public Notification
Drugs
05/22/2019
Man Fuel Male Enhancement Shooter (Tropical Fruit Flavor)
Various Distributors
n/a
gomanfuel.com
Undeclared tadalafil and desmethyl carbodenafil
Public Notification
Drugs
05/16/2019
Green Bali Powder
KratomNC
925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
kratomnc.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
05/16/2019
Red Indo Powder
KratomNC
925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
kratomnc.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
05/16/2019
Gold Bali Powder
KratomNC
925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
kratomnc.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
05/16/2019
White Indo Powder
KratomNC
925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
kratomnc.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
05/16/2019
Super White Powder
KratomNC
925 S. Kerr Ave. Suite M2, Wilmington, NC 28403-4335
kratomnc.com
Unapproved New Drug/Misbranded
Warning Letter
Drugs
05/15/2019
Active Herb YinVive
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Active Herb Ease Tonic
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Active Herb LiverVive
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Vertigoff (Ban Xia Bai Zhu Tian Ma Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Nasopass (Bi Yan Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang NeuroSoothe (Chai Hu Long Gu Lu Mu Li Pian (Wan)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang JointsJoy (Du Huo Ji Sheng Wan)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Cardiovigor (Fu Fang Dan Shen Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Kudzu Relaxe (Ge Gen Tang Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Stomacare (Huo Xiang Zheng Qi Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Breathmooth (Ke Chuan Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Stonepass (Li Shui Pai Shi Pian)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/15/2019
Guang Ci Tang Bupleuri Relaxe (Xiao Chai Hu Pian (Wan)
ActiveHerb Technology, Inc.
8830 Rehco Rd., Ste. ESan Diego, CA 92121-3263
activeherb.com
Unapproved New Drugs/Misbranded
Warning Letter
Foods
05/07/2019
Topical Sunscreen and Anti-Blemish Over-the-Counter (OTC) Drug Products
AMMD Labs, LLC
1501 Green Rd Ste J, Pompano Beach, FL 33064
n/a
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
05/07/2019
The BEAST Capsules
STIFF BOY LLC
n/a
n/a
Undeclared sildenafil
Recall
Drugs
05/02/2019
Puriton Eye Relief Drops
Kadesh International
7341 Lincoln Way, Garden Grove, CA 92841
puriton.us
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
05/02/2019
Puriton Intimate Disinfection Spray
Kadesh International
7341 Lincoln Way, Garden Grove, CA 92841
puriton.us
CGMP/Finished Pharmaceuticals/Adulterated
Warning Letter
Drugs
04/23/2019
Fever~Infection
Newton Laboratories Inc DBA Newton Homeopathics
455 Gees Mill Business Ct. NE, Conyers, GA 30013
newtonlabs.net
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Warning Letter
Drugs
04/23/2019
Food Allergies~Additives
Newton Laboratories Inc DBA Newton Homeopathics
455 Gees Mill Business Ct. NE, Conyers, GA 30013
newtonlabs.net
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Warning Letter
Drugs
04/23/2019
Blues~Mood~Emotions
Newton Laboratories Inc DBA Newton Homeopathics
455 Gees Mill Business Ct. NE, Conyers, GA 30013
newtonlabs.net
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Warning Letter
Drugs
04/23/2019
Vaccination~Illness
Newton Laboratories Inc DBA Newton Homeopathics
455 Gees Mill Business Ct. NE, Conyers, GA 30013
newtonlabs.net
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Warning Letter
Drugs
04/09/2019
Platinum 40000
SD Imports, LLC
n/a
n/a
Undeclared sildenafil
Recall
Drugs
04/05/2019
Kopi Jantan Tradisional Natural Herbs Coffee
Brian Richardson dba In Tha Pink
n/a
n/a
Undeclared sildenafiland tadalafil
Recall
Drugs
03/22/2019
LEOPARD Miracle Honey
USA LESS
PO Box 250-138, Brooklyn, NY 11225
n/a
Undeclared sildenafil
Recall
Drugs
03/21/2019
BLUEFUSION Capsules
Ata Int. Inc.
n/a
n/a
Undeclared sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein
Recall
Drugs
02/08/2019
Indian Herb
McDaniel Life-Line LLC
n/a
n/a
Marketed without an approved NDA/ANDA
Recall
Drugs
01/29/2019
Silver Bullet 10x
Nature's Rx
n/a
n/a
Undeclared sildenafil and tadalafil
Recall
Drugs
01/28/2019
GoLean Detox
GoLean Detox US
4832 Central Ave, Charlotte, NC 28205-5844
facebook.com/GoLean-detox-US-1592137147568285/
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
Warning Letter
01/28/2019
Ultra Fit
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
01/28/2019
Slimmer Extreme Thermogenic Formula
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
01/28/2019
Slim Bio Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydramine
Public Notification
Drugs
01/28/2019
Slimina
Various Distributors
n/a
effectivehealthyproducts.com
Undeclared sibutramine
Public Notification
Drugs
01/28/2019
Red Stallion Extra Strong
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
01/28/2019
Natural V=GRA
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
01/28/2019
Yong Gang
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
01/28/2019
Golden Ant
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
01/28/2019
Instinct Best Sexual Enjoyment
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
01/28/2019
Nectar Del Amor
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
01/10/2013
1 Day Diet
Various Distributors
n/a
n/a
Undeclared N-desmethylsibutramine
Public Notification
Drugs
01/10/2019
Black King Kong
Various Distributors
n/a
International Mail Shipments
Undeclared moroxydine and sildenafil
Public Notification
Drugs
01/10/2019
The Silver Bullet
Various Distributors
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
01/08/2019
Rhino 5K
Happy Together, Inc.
504 Muirfield Dr., Atlantis FL, 33462
n/a
Undeclared sildenafil and tadalafil
Recall
Drugs
12/10/2018
On Demand
Various Distributors
n/a
goodlifeondemand.com
Undeclared sildenafil
Public Notification
Drugs
11/30/2018
Willy Go Wild
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
11/30/2018
MOB Candy
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
11/21/2018
America Treasure
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/08/2018
Memory Revitalizer
Alzheimer's Corporation (ALZcorp)
6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110
lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com
New drugs
Online Advisory Letter
Foods; Drugs
11/08/2018
Cerebara GPC (L-Alpha glycerophosphocholine)
Alzheimer's Corporation (ALZcorp)
6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110
lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com
New drugs
Online Advisory Letter
Foods; Drugs
11/08/2018
Life Imagined
Alzheimer's Corporation (ALZcorp)
6000 Uptown Blvd., NE Suite 308 Albuquerque, NM 87110
lifeimagined.com; alzheimerscorp.com; memoryrevitalizer.com; alzcorp.com
New drugs
Online Advisory Letter
Foods; Drugs
11/08/2018
Mind and Memory Support
Alzheimer's Organization
509 Riverside Drive, Suite 302 Stuart, FL 34994
alzheimersorganization.org
New drugs
Online Advisory Letter
Foods; Drugs
11/08/2018
Leopard Secret Miracle Honey
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil
Public Notification
Drugs
11/08/2018
Best Leopard Miracle of Honey
Various Distributors
n/a
Examination of imported goods
Undeclared sildenafil and tadalafil
Public Notification
Drugs
11/08/2018
Gold Max Blue
Various Distributors
n/a
goldmaxblue.com
Undeclared sildenafil
Public Notification
Drugs
11/07/2018
BALI Greens
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
BALI Purples
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
Black Seed Oil
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
DHEA Capsules
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
Lugol’s Solution 2% Drops
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
Robenyzme Capsules
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
OMG Max Drops
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
New Dawn Capsules
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
Vitamin C with R-Lipoic Acid
Dr. Fitt Intelligent Designs, LLC
812 S Georgia St Amarillo, TX 79106
drfitt.com; drfittinfo.com
New Drugs
Online Advisory Letter
Foods; Drugs
Warning Letter
11/07/2018
Aromatherapy for Dementia Memory Kit Premier Edition
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Aromatherapy for Dementia Memory Kit Second Edition
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Bodyguard Blend Essential Oil
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
ClearMind Blend Essential Oil
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Lavender Essential Oil
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Attention Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Calming Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Lavender Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Perk Up Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Refresh Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Rested Aromatherapy Patch
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Aromatherapy Patch Sample Pack
Healthcare Products, LLC d/b/a The Alzheimer's Store d/b/a MindCare Store
340 Royal Poinciana Way, #317 Palm Beach, FL 33480
alzstore.com; mindcarestore.com; facebook.com/TheAlzheimersStore/; twitter.com/alzstore; facebook.com/MindCareStore/; twitter.com/MindCareStore
New Drugs
Online Advisory Letter
Foods; Drugs
11/07/2018
Essential Oils including Dementia/Alzheimer's (Day) Synergy Oil and Dementia/Alzheimer's (Night) Synergy Oil
This Wonderful Life New Age Shop
M-0-7, Plaza Damas 60 Jalan Sri Hartamas 1 Kuala Lumpur, 50480 Malaysia MY
twlshop.com
New Drugs
Online Advisory Letter
Foods; Drugs
10/15/2018
Zero Xtreme
Fat Burners Zone
n/a
n/a
Undeclared sibutramine
Recall
Drugs
10/01/2018
FX75000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/01/2018
Baschi Quick Slimming Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
10/01/2018
In Shape
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/01/2018
Like Slim Coffee
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/01/2018
Shengan Natural Model
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/01/2018
Green Lean Body Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
10/01/2018
Strong Horses
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/01/2018
USA for Woman
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/01/2018
V-Max
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/01/2018
ProSolution
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
09/06/2018
Purblack
Adaptive Energy LLC
109 E 17th St. Ste 4, Cheyenne, WY 82001
purblack.com
New Drug/Misbranded
Warning Letter
Foods
Close-out Letter
08/31/2018
Easy 2 Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
08/31/2018
Slimming Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
08/31/2018
Extenze Nutritional Supplement
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/31/2018
BodySlim Herbal
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
08/31/2018
Extenze Plus
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/31/2018
PremierZen Gold 4000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/31/2018
5K
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/31/2018
Panther Power Platinum 11000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/31/2018
Nuvitra
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and fluoxetine
Public Notification
Drugs
08/31/2018
XXXPlosion Ultra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/29/2018
Cell Stop
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
Cardio Forte
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
Inflam-Alieve
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
Liv Assist
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
Mindful
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
GI Comfort
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/29/2018
Tranquil
Optimal Health Knowledge LLC
2177 NE 62nd Ct. Fort Lauderdale, FL 33308
optimalhealthknowledge.com; facebook.com/optimalhealthknowledge/
New Drugs
Online Advisory Letter
Foods; Drugs
08/10/2018
Ding Ji Wei Ge
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/31/2018
Black Rhino 25000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/31/2018
Gold Rhino 25000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/31/2018
Boss Rhino 15000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/31/2018
Platinum Rhino 25000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/31/2018
Krazzy Rhino
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/16/2018
Rhino 8 Platinum 8000
Various Distributors
n/a
n/a
Undeclared N-desmethylsibutramine, phenolphthalein, diclofenac, and sildenafil
Public Notification
Drugs
07/11/2018
Platinum Maximum Strength Blue Pill Version
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
Consent Decree
07/11/2018
Slimming Plus Advanced Weight Loss
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
African Viagra
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
GINSENG
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
African Superman
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
Old Chinese
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
Lean Extreme Max
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine
Recall
Drugs
Consent Decree
07/11/2018
X-treme Beauty Slim
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine
Recall
Drugs
Consent Decree
07/11/2018
African Superman - Top-Class Permanence Tablet
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sildenafil
Recall
Drugs
Consent Decree
07/11/2018
Slim Evolution
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared diclofenac
Recall
Drugs
Consent Decree
07/11/2018
Fat Loss Slimming Beauty
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
Consent Decree
07/11/2018
Fruta Planta
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
Consent Decree
07/11/2018
Botanical Slimming
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared API
Recall
Drugs
Consent Decree
07/11/2018
Slim Body
MyNicNaxs, LLC
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared API
Recall
Drugs
Consent Decree
07/09/2018
Asunsa
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac
Public Notification
Drugs
07/09/2018
C.U. Plus
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
07/09/2018
Lyn DTOX FS3
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and N-desmethylsibutramine
Public Notification
Drugs
07/09/2018
Dale Mas
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
07/09/2018
Grakcu Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
07/09/2018
Maximum Powerful
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/03/2018
Body Shape Weight Loss
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein
Public Notification
Drugs
07/03/2018
Row of Antibody Pil
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
07/03/2018
Chong Cao Qiang Shen Wang
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein
Public Notification
Drugs
07/03/2018
Adipotrim XT
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein
Public Notification
Drugs
07/03/2018
Maxidus
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/20/2018
Gold Viagra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/20/2018
AB Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, phenolphthalein and sildenafil
Public Notification
Drugs
06/20/2018
Adriana Balance S
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
06/20/2018
Black Stallion 35000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/20/2018
XXXPlosion
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
06/07/2018
PAYA Dietary Supplement Product
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
06/07/2018
Crossroads Wellness Beverage
Up Inya Gear
22 Centennial St., Fairfield, PA 17320
crossroads2freeedom.com; upinyabeverages.com
New Drug/Misbranded
Warning Letter
Foods
Close-out Letter
05/18/2018
Solaricare
Pharmacy Direct, PDU
8 The Green, Suite 5871, Dover, DE 19901
solaricare.com
New Drug/Labeling/Misbranded
Warning Letter
Foods
Close-out Letter
05/17/2018
7K
Shoreside Enterprises, Inc.
6345 Newtown Circle A-3, Tampa, FL 33615
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
05/17/2018
Poseidon 4500 (Extreme 1000 mg)
Shoreside Enterprises, Inc.
6345 Newtown Circle A-3, Tampa, FL 33615
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
05/14/2018
MediViral Extra Strength Herpes Treatment
MediViral, Inc
PO Box 56822 Los Angeles, CA 91413
mediviral.com; twitter.com/mediviral
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
MediViral Extra Strength Herpes Topical Treatment
MediViral, Inc
PO Box 56822 Los Angeles, CA 91413
mediviral.com; twitter.com/mediviral
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Anti-Stroke
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Bones
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Viral-X
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Candida
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Iron Infusion
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Mental Focus
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Natural Cancer Fighter
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Sugar Diabetes Control
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Niagra
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
“Honey, I’m Home” Body Wash
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
“Ancient Healing Herbs” Body Wash
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
“Cinnamon Sensations” Body Wash
Olivia’s Healing Herbs
1102 Edgefield St. Killeen, TX 75649-2112
oliviashealingherbs.com
New Drugs
Online Advisory Letter
Foods; Drugs
05/14/2018
Best Candy
Various Distributors
n/a
Examination of Imported Goods
Undeclared nortadalafil
Public Notification
Drugs
03/28/2018
Black Lion Pill
Various Distributors
n/a
rakuten.com
Undeclared sildenafil
Public Notification
Drugs
03/28/2018
Red Zone Xtreme 3000
Various Distributors
n/a
ebay.com
Undeclared tadalafil
Public Notification
Drugs
03/28/2018
Rhino 69 Extreme 50000
AMA Wholesale Inc.
n/a
bonanza.com
Undeclared tadalafil
Public Notification
Drugs
Recall
03/28/2018
Blue Pearl All Natural Male Enhancement Supplement
Marmex Corp
n/a
n/a
Undeclared sildenafil
Recall
Drugs
12/06/2017
After Gallbladder Removal Kit
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Beet Root Capsules
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
30 Day Gallbladder Solution
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Bile Salts
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Choline
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Dissolve GS
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Gallbladder ND Detox
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Gallstone Kit
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Glutathione Liposomal Liquid
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Liver Detox Kit
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Liver ND Detox
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Peppermint Oil Capsules
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Tranquinol
Gallbladder Attack
n/a
gallbladderattack.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Prostalgene Oral Drops
Prostalgene LLC
n/a
prostalgene.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Shilajit Resin
Healthy Nutrition Group LLC
n/a
naturalshilajit.com; organicagsolutions.org
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
NutriHoney
Healthy Nutrition Group LLC
n/a
naturalshilajit.com; organicagsolutions.org
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Bulk Shilajit
Healthy Nutrition Group LLC
n/a
naturalshilajit.com; organicagsolutions.org
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Combination Herpes Treatment
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
L-Lysine
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Tribulus
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Astragalus
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Rhodiola
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Amino Acid Formula (or “Unique Amino Formula”)
Synergy Health Solutions
n/a
cure4herpes.com; treatment4herpes.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Curos Essential
Cura Care, Inc.
n/a
getcuros.com
New Drugs
Online Advisory Letter
Foods; Drugs
12/06/2017
Chill6
Chill6
26 Valley Forge Cir. West Boylston, MA 01583
chill6.com
Unapproved New Drugs/Misbranded
Online Advisory Letter
Drugs
Warning Letter
11/30/2017
Chao Jimengnan
Nutra Labs Inc.
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
11/30/2017
Bull
Nutra Labs Inc.
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
11/22/2017
Asia Slim Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, diazepam, and bisacodyl
Public Notification
Drugs
11/20/2017
New Stiff Nights Platinum 10k
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Pro Solution
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Qibianli
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Rhino 11 Platinum 11000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Rhino 12 Titanium 6000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Rhino 25K 15000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Rhino 69 Premium 8000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
S.W.A.G. II Platinum 33K
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
V9 Male Sexual Stimulant
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Tyrannosaurus
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Fruta Planta Life (Garcinia Cambogia Premium)
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
11/20/2017
Adipessum Miracle Slimming Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared fluoxetine
Public Notification
Drugs
11/20/2017
MenXtrong
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Blue Diamond Pill
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Control Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/20/2017
Blue Pearl All Natural Male Enhancement
Various Distributors
n/a
bluepearlformen.com; bluefusions.com
Undeclared sildenafil
Public Notification
Drugs
11/09/2017
Hard Times for Men
Various Distributors
n/a
blankterrmall.com
Undeclared sildenafil
Public Notification
Drugs
10/30/2017
Linsen Double Caulis Plus (靈仙双藤素)
Various Distributors
n/a
tranpharma.com
Undeclared dexamethasone
Public Notification
Drugs
10/10/2017
Tiger 5000
Various Distributors
n/a
amazon.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
10/04/2017
A1 Slim
Kiriko, LLC
Houston, TX
n/a
Undeclared sibutramine, phenolphthalein and N-Desmethyl sibutramine
Recall
Drugs
09/20/2017
Vegetable Vigra
Natures Supplement, Inc.
n/a
n/a
Undeclared sildenafil
Recall
Drugs
09/20/2017
Rhino 7 Platinum 5000
Gadget Island, Inc. dba Gear Isle
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Recall
Drugs
Expanded Recall
09/20/2017
Papa Zen 3300
Gadget Island, Inc. dba Gear Isle
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Recall
Drugs
Expanded Recall
09/20/2017
Fifty Shades 6000
Gadget Island, Inc. dba Gear Isle
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Recall
Drugs
Expanded Recall
09/20/2017
Grande X 5800
Gadget Island, Inc. dba Gear Isle
n/a
gearisle.com
Undeclared sildenafil and tadalafil
Recall
Drugs
Expanded Recall
08/31/2017
Physic Candy - Define
Various Distributors
n/a
physic-candy.com
Undeclared sibutramine
Public Notification
Drugs
08/31/2017
Physic Candy - Curve
Various Distributors
n/a
physic-candy.com
Undeclared sibutramine
Public Notification
Drugs
08/01/2017
AMPT Coffee
The AMPT Life, LLC
n/a
amptcoffee.com
Undeclared sildenafil, tadalafil and milk
Public Notification
Drugs
07/24/2017
Xplode
EZ Weight Loss TX
Corpus Christi, TX
n/a
Undeclared sibutramine
Recall
Drugs
07/24/2017
La Bri's Body Health Atomic
EZ Weight Loss TX
Corpus Christi, TX
n/a
Undeclared sibutramine
Recall
Drugs
07/17/2017
Kingdom Honey for Him
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
07/17/2017
Kingdom Honey for Her
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
07/17/2017
Royal Honey VIP
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
07/17/2017
RHINO 7 Platinum 5000
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/29/2017
Agony Balm
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Auburn Oil
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Rose of Sharon Salt/Olive Soap
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Mudd Bombs
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Harmony Castile Soap
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Rouse Oil
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Dew of the Sea Salt/Olive Soap
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Season Infusions
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
Serenity Castile Soap
Hart & Soul Herbal, LLC
n/a
hartandsoulherbal.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
PD Complete
ARS Therapeutics, LLC
n/a
alstreatments.com
New Drugs
Online Advisory Letter
Drugs
06/29/2017
ALS Complete
ARS Therapeutics, LLC
n/a
alstreatments.com
New Drugs
Online Advisory Letter
Drugs
06/23/2017
XXX Zone Platinum
SHH Trading
n/a
n/a
Undeclared sildenafil, tadalafil and dapoxetine
Public Notification
Drugs
06/23/2017
Triple X 2000
SHH Trading
n/a
n/a
Undeclared tadalafil and dapoxetine
Public Notification
Drugs
06/23/2017
Triple Premium Zen Gold 1300mg
SHH Trading
n/a
n/a
Undeclared sildenafil, tadalafil and dapoxetine
Public Notification
Drugs
06/23/2017
Macho Man 3000
SHH Trading
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/22/2017
Monster X 1350
SHH Trading
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/22/2017
Own the Knight 1750
SHH Trading
n/a
n/a
Undeclared tadalafil and dapoxetine
Public Notification
Drugs
06/22/2017
Royal Master 1500
SHH Trading
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/22/2017
Triple Miracle Zen Plus 1200mg
SHH Trading
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
06/22/2017
Xzone Gold
SHH Trading
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
06/22/2017
Man of Steel 2
Various Distributors
n/a
manofsteelpills.com
Undeclared sildenafil
Public Notification
Drugs
06/22/2017
Man of Steel
Various Distributors
n/a
manofsteelpills.com
Undeclared sildenafil
Public Notification
Drugs
06/22/2017
Love Zen 3000
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/22/2017
Super Panther 7K
Various Distributors
n/a
ultraxshop.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
05/25/2017
Caverflo Natural Herbal Coffee
Caverflo.com
n/a
caverflo.com
Undeclared sildenafil, tadalafil, and milk
Recall
Drugs
04/18/2017
Uproar
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Cummor
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Zrect
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Monkey Business
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Xrect
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Rectalis
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Tornado
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Zdaily
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
BigNHard
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Enhancerol Natural Male Enhancement capsules
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared tadalafil, sildenafil and their analogues
Recall
Drugs
04/18/2017
Zrect for Women
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared flibanserin
Recall
Drugs
04/18/2017
LabidaMAX capsules
Organic Herbal Supply, Inc.
n/a
amazon.com; zrect.com
Undeclared flibanserin
Recall
Drugs
03/27/2017
LaBri’s Body Health Atomic
Envy Me
n/a
n/a
Undeclared sibutramine
Recall
Drugs
03/07/2017
Black Ant
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Indian God Lotion
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Evil Root
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Germany Black Gold
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Germany Niubian
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Hard Ten Days
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Lang Yi Hao (Chaonogsuopian)
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Gold Vigra
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Clalis
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Ye Lang Shen
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Zhansheng Weige Chaoyue Xilishi
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Zhonghua Niubian
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Stree Overlord
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Max Man
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Hu Hu Sheng Wei
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Tiger King
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Viagra 100
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Power V8 Viagra
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Daidiyongshi Xiangganglongshengwu
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Lien Chan for Seven Days
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/07/2017
Maca Gold
A&H Focal Inc.
n/a
n/a
Undeclared PDE-5 Inhibitors
Recall
Drugs
03/03/2017
Arouse-Plus
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
03/03/2017
Bazook Bullet
Various Distributors
n/a
n/a
Undeclared aminotadalafil
Public Notification
Drugs
02/03/2017
Platinum Max Strength Blue Pill Version
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
02/03/2017
Ginseng for Reinforcing Kidney
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
02/03/2017
Goldreallas Original
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
02/03/2017
Platinum Weight Solution – Fat Loss Metabolizer
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
02/03/2017
Slimming Plus Advanced
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
02/02/2017
X-treme Beauty Slim
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
02/02/2017
Goldreallas XXX
Various Distributors
n/a
groupon.com
Undeclared sildenafil
Public Notification
Drugs
02/02/2017
Shenjingpian
Various Distributors
n/a
ghpnutrition.com
Undeclared sildenafil
Public Notification
Drugs
02/02/2017
Old Chinese
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
02/02/2017
Lean Extreme Max
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
01/26/2017
XtraHRD Natural Male Enhancement capsules
Organic Herbal Supply, Inc.
n/a
amazon.com
Undeclared N-desmethyl tadalafil
Public Notification
Drugs
Recall
01/10/2017
PNC-27
Patrick, LLC
NV
pnc27.com
Contaminated with the bacteria Variovorax paradoxus; contaminated with the bacteria Ralstonia insidiosa
Drug Safety Alert
Drugs
News Release
12/22/2016
Rhino 8 Platinum 8000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Lang Yi Hao
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Power Male Sexual Stimulant
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
African Viagra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Triple Green Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Queen Slimming Soft Gel
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
12/22/2016
Big Penis Male Sexual Stimulant
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
90° Jiushidu Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Rhino 9 Premium 3500
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Duramaxxx
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Rhino 7K 9000 Male Performance Booster
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Bl4ck 4K Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Black 3K Plus Male Sexual Enhancement Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Black Mamba 2 Premium Male Sexual Stimulant
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
12/22/2016
Rhino 5 1500 Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/29/2016
Megajex Natural Male Sex Enhancer
MS Bionic, Inc.
447 E Gardena Blvd, Gardena, CA 90248-2913
n/a
Undeclared tadalafil and sildenafil
Recall
Drugs
Warning Letter
11/16/2016
ABX Weight Loss
Various Distributors
n/a
zxtbeepollenpills.com
Undeclared sibutramine
Public Notification
Drugs
11/09/2016
Supreme Slim 5.7
Various Distributors
n/a
absolutenaturalweightloss.net
Undeclared phenolphthalein and sildenafil
Public Notification
Drugs
11/09/2016
Ready Man!
Various Distributors
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
11/07/2016
Ultimate Body Tox PRO
Ultimate Body–Tox
High Point, NC
ultimatebodytox.com
Undeclared sibutramine
Public Notification
Drugs
Recall
10/19/2016
Accelerator Boost
Various Distributors
n/a
n/a
Undeclared phenolphthalein
Public Notification
Drugs
10/19/2016
Skinny Bee Diet
Various Distributors
n/a
lovemytrubody.com
Undeclared desmethylsibutramine, sibutramine, and phenolphthalein
Public Notification
Drugs
10/19/2016
Zi Su Body Fat Health II (紫苏瘦身营养素 II)
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/19/2016
Results
Various Distributors
n/a
facebook.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
09/16/2016
Stiff Bull Herbal Coffee
Various Distributors
n/a
International Mail Shipments
Undeclared desmethyl carbodenafil
Public Notification
Drugs
08/30/2016
Kopi Jantan Tradisional Natural Herbs Coffee
Bestherbs Coffee LLC
4250 Claremont Dr, Grand Priarie, TX 75052
n/a
Undeclared desmethyl carbodenafil
Public Notification
Drugs
Recall
08/16/2016
Master Zone 1500
Various Distributors
n/a
amazon.com
Undeclared sildenafil and tadalfil
Public Notification
Drugs
08/16/2016
Love4Long
Various Distributors
n/a
amazon.com
Undeclared sildenafil
Public Notification
Drugs
08/16/2016
One More Knight 1750
Various Distributors
n/a
amazon.com
Undeclared tadalfil and dapoxetine
Public Notification
Drugs
07/11/2016
Dream Body Original Formula
Dream Body Weight Loss
Grand Prairie, TX
dreambodyweightloss.com
Undeclared sibutramine
Public Notification
Drugs
Recall
08/09/2016
Adelgazantes R-II
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
08/09/2016
Anaconda Strong Formula
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/09/2016
Boss-Rhino Gold X-tra Strength
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
08/09/2016
De Guo Hei Bei (徳国黑倍)
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/29/2016
Ziyinzhuangyang
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/28/2016
Zi Xiu Tang Beauty Face & Figure Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein and fluoxetine
Public Notification
Drugs
07/28/2016
Weili (一炮到天亮 or Yi Pao Dao Tian Liang)
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/28/2016
Ultimate Lean
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
07/27/2016
Mang Luk Power Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
07/27/2016
Libigirl
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/27/2016
Maxx Easy
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
07/27/2016
Mang Luk Power Slim
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
07/27/2016
Power Spring (XXX) Oral Liquid
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/27/2016
Super Bull 6000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/27/2016
Slim Fit X
Various Distributors
n/a
jerseyshoresupplements.com
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
07/27/2016
Shangai Ultra X
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/27/2016
The Golden Root
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/27/2016
Super Shangai
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
07/22/2016
Xcelerated Weight Loss Charged Up
Various Distributors
n/a
xceleratedweightloss.com
Undeclared sibutramine
Public Notification
Drugs
07/22/2016
Xcelerated Weight Loss Turbo Charge
Various Distributors
n/a
xceleratedweightloss.com
Undeclared sibutramine
Public Notification
Drugs
07/22/2016
Xcelerated Weight Loss Ultra Max
Various Distributors
n/a
xceleratedweightloss.com
Undeclared phenolphthalein and sildenafil
Public Notification
Drugs
07/11/2016
Extra Slim Plus Acai Berry Weight Loss Formula
Various Distributors
n/a
dreambodyweightloss.com
Undeclared sibutramine
Public Notification
Drugs
07/11/2016
Dream Body Advanced + Acai Weight Loss & Cleanse
Various Distributors
Grand Prairie, TX
dreambodyweightloss.com
Undeclared sibutramine, fluoxetine and sildenafil
Public Notification
Drugs
Recall
07/11/2016
Dream Body Extreme Gold
Dream Body Weight Loss
Grand Prairie, TX
dreambodyweightloss.com
Undeclared sibutramine, fluoxetine and sildenafil
Public Notification
Drugs
Recall
07/11/2016
SBF Bee Pollen
Various Distributors
n/a
zxtbeepollen.com
Undeclared sibutramine
Public Notification
Drugs
06/07/2016
Step 2
The Body Shot Bar
n/a
thebodyshotbar.com
Undeclared sibutramine
Public Notification
Drugs
Recall
06/30/2016
My Steel Woody
Various Distributors
n/a
mysteelwoody.com
Undeclared sildenafil
Public Notification
Drugs
06/06/2016
Exhilarate
Various Distributors
n/a
n/a
Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
Public Notification
Drugs
06/01/2016
DR’s Secret Bio Herbs Coffee
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
04/26/2016
3rd Degree
Making It A Lifestyle, L.L.C.
Corpus Christi, TX
makingitalifestyle.com
Undeclared sibutramine
Public Notification
Drugs
Recall
04/26/2016
Black Label X
Making It A Lifestyle, L.L.C.
Corpus Christi, TX
makingitalifestyle.com
Undeclared sildenafil
Public Notification
Drugs
Recall
04/26/2016
Black Gold X Advanced
Making It A Lifestyle, L.L.C.
Corpus Christi, TX
makingitalifestyle.com
Undeclared sibutramine
Public Notification
Drugs
Recall
03/29/2016
Propell Platinum
Various Distributors
n/a
zxtbeepollenpills.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
03/28/2016
ENVY BP
Various Distributors
n/a
purelysimpleweightloss.com
Undeclared sibutramine
Public Notification
Drugs
03/17/2016
Salute Capsules
Various Distributors
n/a
n/a
Undeclared sildenafil, thiosildenafil, and sulfoaildenafil
Public Notification
Drugs
03/17/2016
Xerophagy
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
03/17/2016
ZlimXter Capsules
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
03/17/2016
Dynamizm Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
03/17/2016
Eradicate Capsules
Various Distributors
n/a
x2zero.com
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
03/03/2016
Sextra
Various Distributors
n/a
ishopLSTV.com
Undeclared sildenafil
Public Notification
Drugs
02/11/2016
Zhong Hua Niu Bian
Various Distributors
n/a
zhonghuaniubian.com
Undeclared sildenafil
Public Notification
Drugs
02/11/2016
Weekend Prince
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/11/2016
Bull
Various Distributors
n/a
bullsexpills.com
Undeclared sildenafil
Public Notification
Drugs
02/11/2016
Bull's Genital
Various Distributors
n/a
bullsgenital.com
Undeclared sildenafil
Public Notification
Drugs
02/05/2016
Ninja-X
Various Distributors
n/a
n/a
Undeclared sildenafil and thiosildenafil
Public Notification
Drugs
02/05/2016
Golden Night
Various Distributors
n/a
n/a
Undeclared sildenafil and hydroxythiohomosildenafil
Public Notification
Drugs
02/05/2016
Ginseng Power-X
Various Distributors
n/a
n/a
Undeclared sildenafil and sulfoaildenafil
Public Notification
Drugs
02/05/2016
Boss Number #Six
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
02/05/2016
Mamba is Hero
Various Distributors
n/a
n/a
Undeclared sildenafil, desmethyl carbodenafil, and dapoxetine
Public Notification
Drugs
01/26/2016
Wonder-Erect Male Pills
Various Distributors
n/a
amazon.com
Undeclared vardenafil
Public Notification
Drugs
01/21/2016
Wonder-Erect Male Gum
Various Distributors
n/a
amazon.com
Undeclared vardenafil
Public Notification
Drugs
12/28/2015
Xtra Zone 2400
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/28/2015
Triple MiracleZen Extreme 1750mg
Various Distributors
n/a
n/a
Undeclared sildenafil, tadalafil and dapoxetine
Public Notification
Drugs
12/28/2015
Eros Power Zone 1900
Various Distributors
n/a
n/a
Undeclared desmethyl carbodenafil and dapoxetine
Public Notification
Drugs
12/28/2015
Triple MiracleZen Gold 1750mg
Various Distributors
n/a
n/a
Undeclared sildenafil, tadalafil and dapoxetine
Public Notification
Drugs
12/28/2015
Rhino Big Horn 3000
Various Distributors
n/a
n/a
Undeclared desmethyl carbodenafil and sildenafil
Public Notification
Drugs
12/28/2015
Rhino 7 Blue 9000
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/28/2015
OrgaZen 3000
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/28/2015
Diamond 3500
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/28/2015
Xtra Zone 2200
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/28/2015
Xtra Zone 2600
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/28/2015
Triple Power Zen Plus 2000
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
12/28/2015
OrgaZen 3500
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
12/21/2015
La'Trim Plus
Various Distributors
n/a
bee-xtreme.com
Undeclared sibutramine
Public Notification
Drugs
12/19/2015
Super Herbs
Various Distributors
n/a
mysuperherbs.com
Undeclared sibutramine and desmethylsiburamine
Public Notification
Drugs
12/18/2015
Jenesis
Various Distributors
n/a
beeextremelyamazed.com; beefitamy.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
12/18/2015
Oasis Bee Pollen
Various Distributors
n/a
beeextremelyamazed.com; beefitamy.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
12/18/2015
Prime Bee Pollen
Various Distributors
n/a
beeextremelyamazed.com; beefitamy.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
12/18/2015
Evolve Bee Pollen
Various Distributors
n/a
beeextremelyamazed.com; beefitamy.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
12/18/2015
X Again Platinum
Various Distributors
n/a
paramount-supplements.com
Undeclared sildenafil, tadalafil and dapoxetine
Public Notification
Drugs
12/17/2015
Thirty Plus
Various Distributors
n/a
getskinny.bigcartel.com
Undeclared sibutramine
Public Notification
Drugs
12/17/2015
Power Tiger-X
Various Distributors
n/a
everestwholesales.com
Undeclared sulfoaildenafil
Public Notification
Drugs
12/09/2015
Pink Bikini
Lucy's Weight Loss System
Arlington, TX
pink.bikini.bigcartel.com
Undeclared diclofenac
Recall
Drugs
12/02/2015
Lipo Escultura
Various Distributors, including JAT Productos Naturales Corp.
n/a
lipoesculturatreatment.com
Undeclared sibutramine and diclofenac
Public Notification
Drugs
Recall
11/19/2015
Zero Fat
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and fluoxetine
Public Notification
Drugs
11/19/2015
Effective Viagra Tablets
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/19/2015
Slyn Both
Various Distributors
n/a
International Mail Shipments
Undeclared fluoxetine and orlistat
Public Notification
Drugs
11/19/2015
Super Herbs
Various Distributors
n/a
mysuperherbs.com
Undeclared sibutramine and desmethylsiburamine
Public Notification
Drugs
11/19/2015
Rhino X
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/19/2015
SPCARET Princess Diet
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
11/19/2015
Perfect Slim Fast Track Slim
Various Distributors
n/a
International Mail Shipments
Undeclared fluoxetine and orlistat
Public Notification
Drugs
11/19/2015
Australia Kangaroo Essence
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/19/2015
Sex Drive Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
11/19/2015
XForMan Plus
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/29/2015
Rhino 7 3000
National Video Supply
21100 Centre Pointe Park Way, Santa Clarita, CA 91350
n/a
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/29/2015
Rhino 7 Platinum 3000
National Video Supply
21100 Centre Pointe Park Way, Santa Clarita, CA 91350
n/a
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/28/2015
Rhino 7 3000
Premiere Sales Group
21446 Golden Triangle Rd., Santa Clarita, CA 91350
n/a
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/28/2015
Rhino 7 Platinum 3000
Premiere Sales Group
21446 Golden Triangle Rd., Santa Clarita, CA 91350
n/a
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/23/2015
Fuel Up Plus
Reesna Inc.
Canoga Park, CA
fueluppills.com
Undeclared hydroxythiohomosildenafil
Public Notification
Drugs
Recall
10/23/2015
Fuel Up High Octane
Reesna Inc.
Canoga Park, CA
fueluppills.com
Undeclared hydroxythiohomosildenafil
Public Notification
Drugs
Recall
10/23/2015
S.W.A.G.G.E.R Extreme Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
Lishou Slimming Coffee
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/23/2015
Xtreme Fat Burner Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein and sildenafil
Public Notification
Drugs
10/23/2015
Tip-Top Shape
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/23/2015
Wild Sexx Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil and tadalafil
Public Notification
Drugs
10/23/2015
Sex-Love Secret Code Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
APEXXX
Various Distributors
n/a
ebay.com
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
Ultra SX Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
Super Dragon 6000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
Paradise Suplemento Natural Ultra Plus Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
10/23/2015
Basha Nut 100% Fruit Soft Gel Capsules
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
10/09/2015
Rhino 7 3000
TF Supplements
6666 Gulf Freeway, Houston, TX
International Mail Shipments
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/09/2015
Rhino 7 Platinum 3000
TF Supplements
6666 Gulf Freeway, Houston, TX
International Mail Shipments
Undeclared desmethyl carbondenafil and dapoxetine
Recall
Drugs
10/01/2015
NATUREAL
Various Distributors
n/a
naturealfs.com
Undeclared sibutramine
Public Notification
Drugs
10/01/2015
Ultimate Herbal Slimcap
Various Distributors
n/a
fitfirmandfabulous.com
Undeclared sibutramine
Public Notification
Drugs
09/23/2015
Shorts on the Beach Blue and Gold Edition
Lucy's Weight Loss System
n/a
n/a
Undeclared sibutramine and phenolphthalein
Recall
Drugs
09/23/2015
Pink Bikini
Lucy's Weight Loss System
n/a
n/a
Undeclared sibutramine and phenolphthalein
Recall
Drugs
09/11/2015
Miracle Diet 30
The One Minute Miracle Inc.
3322 NE 166 Street, North Miami Beach, FL 33160
n/a
Undeclared phenolphthalein
Recall
Drugs
Warning Letter
09/11/2015
Miracle Diet 48
The One Minute Miracle Inc.
3322 NE 166 Street, North Miami Beach, FL 33160
n/a
Undeclared thiosildenafil
Recall
Drugs
Warning Letter
09/04/2015
Vimax
Various Distributors
n/a
International Mail Shipments
Undeclared tadalafil
Public Notification
Drugs
09/04/2015
Meizi Super Power Fruits Herbal Slimming Formula
Various Distributors
n/a
slimeast.com
Undeclared sibutramine
Public Notification
Drugs
08/06/2015
Kaboom Actions Strip 12 Pack
Blue Square Market Inc.
North Huntingdon, PA
calcompnutrition.com
Undeclared sulfoaildenafil
Recall
Drugs
08/06/2015
LiDa DaiDaiHua
Blue Square Market Inc.
North Huntingdon, PA
calcompnutriton.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
08/06/2015
Achieving Zero
Various Distributors
n/a
amazon.com
Undeclared sibutramine
Public Notification
Drugs
07/02/2015
Akttive Capsules
Life & More, L.L.C.
Miami, FL
akttive.com
Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
Public Notification
Drugs
Recall
07/02/2015
Zero Xtreme
Fat Burners Zone
n/a
zeroxtremeusa.com
Undeclared sibutramine and desmethylsibutramine
Public Notification
Drugs
Recall
06/12/2015
Pyrola
G&C Natural Nutrition, Inc,
Fullerton, CA
N/A
Undeclared diclofenac
Recall
Drugs
06/05/2015
Pyrola Advanced Joint Formula
Various Distributors
n/a
amazon.com
Undeclared diclofenac
Public Notification
Drugs
06/05/2014
Zhen Gong Fu
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/03/2015
Smart Lipo
SmartLipo365 and Centro Naturista
2915 East Division Street, Suite 523, Arlington, TX76011
smartlipo365.com
Undeclared sibutramine, desmethylsibutramine, and phenolphthalein
Recall
Drugs
Expanded Recall
Warning Letter
05/12/2015
Slim Xtreme Diamond
Globe All Wellness
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
05/12/2015
Slim Xtreme Platinum
Globe All Wellness
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
05/04/2015
Jianbu Huqian Wan
Various Distributors
n/a
International Mail Shipments
Undeclared dexamethasone, chlorpheniramine, and furosemide
Public Notification
Drugs
05/04/2015
Saurean Fong Sep Lin
Various Distributors
n/a
International Mail Shipments
Undeclared dexamethasone and cyproheptadine
Public Notification
Drugs
05/04/2015
Asihuri Plus Forte
Various Distributors
n/a
International Mail Shipments
Undeclared dexamethasone and phenylbutazone
Public Notification
Drugs
05/04/2015
Ginseng She Lian Wan
Various Distributors
n/a
International Mail Shipments
Undeclared dexamethasone and chlorpheniramine
Public Notification
Drugs
04/30/2015
King of Romance
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
04/30/2015
Viagra 007
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
04/30/2015
Slim Forte Slimming Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
04/30/2015
Li Da Dai Dai Hua Slimming Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
04/30/2015
Black Panther
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
04/29/2015
Fatloss Slimming Beauty
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
04/29/2015
Superior
Various Distributors
n/a
detoxtheweightaway.com; beeallnatural.net
Undeclared sibutramine
Public Notification
Drugs
09/12/2014
Mezo
Various Distributors
n/a
n/a
Undeclared benzylsibutramine
Public Notification
Drugs
04/21/2015
Extreme Diamond 3000
Various Distributors
n/a
libidoshops.com
Undeclared desmethyl carbodenafil and dapoxetine
Public Notification
Drugs
03/26/2015
Green Algae Combination
Crane Beauty
n/a
International Mail Shipments
Undeclared lorcaserin
Public Notification
Drugs
03/18/2015
Xcel Advanced
Various Distributors
n/a
beenaturalnutrition.com
Undeclared phenolphthalein
Public Notification
Drugs
03/18/2015
Ultimate Boost
Various Distributors
n/a
sportnutrition1.com
Undeclared phenolphthalein
Public Notification
Drugs
03/18/2015
Xcel
Various Distributors
n/a
zixiutangforyourfigure.com
Undeclared fluoxetine
Public Notification
Drugs
03/18/2015
Xcel Advanced
Various Distributors
n/a
beenaturalnutrition.com
Undeclared phenolphthalein
Public Notification
Drugs
03/10/2015
UltraZx
UltraZx, Labs, L.L.C.
n/a
n/a
Undeclared sibutramine and phenolphthalein
Recall
Drugs
03/05/2015
Black Mamba Premium
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/05/2015
Black Mamba Hyperrush
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
03/05/2015
African Superman
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/05/2015
L-Carnitine Sob Strengthening Version Slimming Miracle Capsule
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
03/05/2015
Black Ant King
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/05/2015
Bigger Longer More Time More Sperms
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/03/2015
Herb Viagra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/03/2015
Natural Max Slimming
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil, fluoxetine and sibutramine
Public Notification
Drugs
03/03/2015
Diablos Eca Fire Caps
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil, phenolphthalein, sibutramine and an analogue of sibutramine, deisobutylbenzylsibutramine
Public Notification
Drugs
03/03/2015
Stiff Nights
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/03/2015
Male Silkworm Moth Nourishing Oral Liquid
Various Distributors
n/a
International Mail Shipments
Undeclared vardenafil
Public Notification
Drugs
03/03/2015
Baolong
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/03/2015
Rhino Blitz Gold 3000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/03/2015
Vim-25
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
MME MAXMAN
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
FX3000
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Hard Wang
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Vigour 300
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Santi Scalper
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Plant Vigra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Vigra
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Elimulating Weight & Toxin Keeping Beauty
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine
Public Notification
Drugs
03/02/2015
Super Hard
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
03/02/2015
Sex Men
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/28/2015
Seven Slim
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein
Public Notification
Drugs
02/28/2015
Night Man
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/28/2015
Libigrow XXX Treme
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/28/2015
Nine Slim
Various Distributors
n/a
International Mail Shipments
Undeclared phenolphthalein
Public Notification
Drugs
02/28/2015
Oxy ELITE Pro Super Thermogenic
Various Distributors
n/a
International Mail Shipments
Undeclared fluoxetine
Public Notification
Drugs
02/27/2015
72HP
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/27/2015
Tibet Babao
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/27/2015
Germany Niubian
Various Distributors
n/a
International Mail Shipments
Undeclared sildenafil
Public Notification
Drugs
02/27/2015
Botanical Slimming (Red)
Various Distributors
n/a
International Mail Shipments
Undeclared fluoxetine
Public Notification
Drugs
02/25/2015
Lean Body Extreme
Various Distributors
n/a
International Mail Shipments
Undeclared sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafil
Public Notification
Drugs
02/09/2015
BtRim Max
Detox Transforms Health and Nutrition
Garner, NC
n/a
Undeclared phenolphthalein
Recall
Drugs
02/09/2015
AMPD Gold Bee Pollen
Detox Transforms Health and Nutrition
Garner, NC
n/a
Undeclared sildenafil
Recall
Drugs
02/09/2015
iNDiGO
Detox Transforms Health and Nutrition
Garner, NC
n/a
Undeclared phenolphthalein
Recall
Drugs
02/09/2015
EDGE Amplified Weight Release
Detox Transforms Health and Nutrition
Garner, NC
n/a
Undeclared phenolphthalein and fluoxetine
Recall
Drugs
02/09/2015
iNSANE Bee Pollen
Detox Transforms Health and Nutrition
Garner, NC
n/a
Undeclared phenolphthalein and fluoxetine
Recall
Drugs
02/03/2015
Yanhee Slim
Various Distributors
n/a
n/a
Undeclared lorcaserin
Public Notification
Drugs
01/21/2015
Happy Passengers
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
12/23/2014
Zhansheng Weige Chaoyue Xilishi
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
12/23/2014
Triple PowerZen
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
12/23/2014
Samurai-X
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
12/23/2014
Slim-K
Bethel Nutritional Consulting, Inc.
New York, NY
bethel30.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
Recall
12/19/2014
B-Lipo
Bethel Nutritional Consulting, Inc.
New York, NY
bethel30.com
Undeclared lorcaserin
Recall
Drugs
11/25/2014
Slim Vie
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/25/2014
Bee Thin
Various Distributors
n/a
beethinzxt.com
Undeclared sibutramine
Public Notification
Drugs
11/24/2014
Super Extreme Accelerator
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/24/2014
Bee Slim
Various Distributors
n/a
International Mail Shipments
Undeclared
Public Notification
Drugs
11/24/2014
Black Storm
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
11/20/2014
Feng Shi Ling by Hong Kong Chi Chun Tang Herbal Factory
Various Distributors
n/a
n/a
Undeclared diclofenac and indomethacin
Public Notification
Drugs
11/19/2014
Forever Beautiful Bee Pollen
REFA Enterprises, LLC
n/a
n/a
Undeclared sibutramine and/or phenolphthalein
Recall
Drugs
11/19/2014
Forever Beautiful Infinity
REFA Enterprises, LLC
n/a
n/a
Undeclared sibutramine and/or phenolphthalein
Recall
Drugs
11/14/2014
Mayhem
Chaotic-Labz
Atkins, AR
n/a
Undeclared dexamethasone
Recall
Drugs
11/04/2014
V26 Slimming Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/30/2014
Ginseng Kianpi Pil
Kweilin Drug Manufactory
n/a
ginsengkianpipil.com
Undeclared dexamethasone
Public Notification
Drugs
10/10/2014
Sit and Slim II
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
09/26/2014
Mojo Risen
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil
Warning Letter
Drugs
09/26/2014
XZone 1200
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil and tadalafil
Warning Letter
Drugs
09/26/2014
XZone Gold
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil and tadalafil
Warning Letter
Drugs
09/26/2014
XZen Platinum
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil and tadalafil
Warning Letter
Drugs
09/26/2014
Black Ant
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil
Warning Letter
Drugs
09/26/2014
African Black Ant
Nova Products, Inc.
5 Mount Pleasant Road, Aston, PA 19014
n/a
Undeclared sildenafil
Warning Letter
Drugs
09/12/2014
LX1
Various Distributors
n/a
drskinsecret.com
Undeclared DMAA
Public Notification
Foods
09/12/2014
Best Line Suplemento Alimenticio Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
08/11/2014
Arize
Various Distributors
n/a
calcompnutrition.com
Undeclared sulfoaildenafil
Public Notification
Drugs
08/11/2014
Herbal Vigor Quick Fix
Various Distributors
n/a
calcompnutrition.com
Undeclared tadalafil
Public Notification
Drugs
07/22/2014
O.M.G
Various Distributors
n/a
sears.com
Undeclared sildenafil
Public Notification
Drugs
07/08/2014
Mix Fruit Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2014
Lipo 8 Burn Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2014
24 Ince
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2014
Sliming Diet By Pretty White
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2014
Lingzhi Cleansed Slim Tea
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2014
Trim-Fast Slimming Softgel
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
06/17/2014
Miraculous Evil Root
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/17/2014
Toxin Discharged Tea
Various Distributors
n/a
n/a
Undeclared fluoxetine
Public Notification
Drugs
06/17/2014
Sport Burner
Various Distributors
n/a
n/a
Undeclared fluoxetine
Public Notification
Drugs
06/17/2014
Gold Vigra
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/17/2014
Sliming Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
06/10/2014
La Jiao Shou Shen
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
06/05/2014
B-Perfect
Various Distributors
n/a
icanb-perfect.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
06/02/2014
Eyeful
Various Distributors
n/a
n/a
Undeclared hydroxythiohomosildenafil
Public Notification
Drugs
06/02/2014
3 Hard Knights
Various Distributors
n/a
n/a
Undeclared sildenafil and thiosildenafi
Public Notification
Drugs
06/02/2014
Liu Bian Li
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/02/2014
Full Throttle On Demand
Various Distributors
n/a
overstock.com
Undeclared propoxyphenyl sildenafil
Public Notification
Drugs
06/02/2014
Dick's Hard Up
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/02/2014
GoldReallas
Various Distributors
n/a
n/a
Undeclared sildenafil and thiosildenafi
Public Notification
Drugs
05/16/2014
MV 5 Days
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
05/16/2014
Asset Bold
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
05/12/2014
Asset Bee Pollen
Various Distributors
n/a
assetcapsules4u.com
Undeclared sibutramine
Public Notification
Drugs
05/05/2014
Natural Body Solution
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
05/05/2014
Slim Trim U
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
04/21/2014
Super Arthgold
Nano Well-being Health Inc.
La Mirada, CA
n/a
Undeclared chlorzoxazone, diclofenac and indomethacin
Recall
Drugs
04/16/2014
S.W.A.G
Various Distributors
n/a
sexwithagrudge.com
Undeclared sildenafil
Public Notification
Drugs
04/10/2014
Lite Fit USA
Various Distributors
n/a
herbsultimate.com
Undeclared sibutramine
Public Notification
Drugs
04/10/2014
Infinity
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
04/09/2014
Thinogenics
Nature’s Universe
n/a
shopnaturesuniverse.com; easy2loseweight.com
Undeclared sibutramine
Recall
Drugs
04/02/2014
New You
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
03/26/2014
Bella Vi Insane Bee Pollen Capsules
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Bella Vi BTrim Ultimate Boost
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Bella Vi BTrim Max
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Bella Vi Extreme Accelerator
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Bella Vi Insane Amp’d
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Bella Vi Amp’d Up
Pure Edge Nutrition, LLC
Toms River, NJ
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Super Fat Burner
New Life Nutritional Center
n/a
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Maxi Gold
New Life Nutritional Center
n/a
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/26/2014
Esmeralda
New Life Nutritional Center
n/a
n/a
Undeclared sibutramine and/or phenophthalein
Recall
Drugs
03/19/2014
Vitaccino Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
03/07/2014
Weekend Warrior
Various Distributors
n/a
onlinecoralcalcium.com
Undeclared thiosildenafil
Public Notification
Drugs
02/13/2014
Arth-Q, “알쓰큐” or “알쓰Q"
Various Distributors
n/a
kaymall.com
Undeclared ibuprofen
Public Notification
Drugs
02/04/2014
Magic Slim
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Fruta Bio
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
SlimEasy
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine and N-desmethylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Super Fat Burning Bomb
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared N-desthylsibutraminea nd phenolphthalein
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Slim Xtreme
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Meizi Evolution
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Meizitang Strong Version Botanical Slimming
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared sibutramine, N-desmethylsibutramine and benzylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Jianfeijindan Activity Girl
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared N-di-desmethylsibutramine
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared phenolphthalein
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
02/04/2014
Reduce Weight Fruta Planta
MyNicNaxs, Inc.
1012 Alpine Dr, Deltona, FL 32725
mynicnaxs.com; ruglamourous.com
Undeclared phenolphthalein
Recall
Drugs
Warning Letter
Additional Recall
Consent Decree
01/28/2014
Bali Mojo
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
01/28/2014
Hot Detox
Various Distributors
n/a
hotdetoxllc.com
Undeclared sibutramine
Public Notification
Drugs
01/28/2014
Citrus Fit Gold
Citrus Fit Weight Loss and Detox Products, LLC
n/a
citrusfit.com
Undeclared sibutramine
Public Notification
Drugs
Warning Letter
01/28/2014
JINQIANGBUDOR Red Dragon
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
01/28/2014
Tiger King
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
01/28/2014
SexRx
Various Distributors
n/a
alternative-health-supplements.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
01/28/2014
Tonic Life BP
Various Distributors
n/a
tonic-life-products.com
Undeclared phenolphthalein
Public Notification
Drugs
01/21/2014
Dream Body Slimming Capsule
Slim Beauty USA
503 E. 23rd St. Kearney, NE 68847
slimbeautyusa.com
Undeclared sibutramine
Public Notification
Drugs
Warning Letter
01/21/2014
Magic Slim
Slim Beauty USA
503 E. 23rd St. Kearney, NE 68847
slimbeautyusa.com
Undeclared sibutramine
Public Notification
Drugs
Warning Letter
01/15/2014
Pro ArthMax
Various Distributors
n/a
n/a
Undeclared diclofenac, ibuprofen, naproxen, indomethacin, nefopam, and chlorzoxazone
Public Notification
Drugs
01/09/2014
Magic for Men
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
Boost Ultra
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
XZone Gold
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
Sexy Monkey
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
Triple MiracleZen Platinum
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
"New" Extenze
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
01/09/2014
New XZen Platinum
Midwest Wholesale
Nixa, MO
n/a
Undeclared sildenafil and/or tadalafil
Recall
Drugs
12/23/2013
Burn 7
Deseo Rebajar Inc.
n/a
deseorebajar.com
Undeclared phenolphthalein
Public Notification
Drugs
Recall
12/23/2013
Mass Destruction
Blunt Force Nutrition
n/a
n/a
Labeled to contain at least one synthetic anabolic steroid
Press Release
Drugs
12/19/2013
SlimEasy Herbs Capsule
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
12/19/2013
CONTROL All Natural Sexual Enhancement
Various Distributors
n/a
n/a
Undeclared sulfoaildenafil and dimethylsildenafil
Public Notification
Drugs
12/19/2013
Asset Extreme Plus
Various Distributors
n/a
allnaturalbeelievers.com
Undeclared sibutramine
Public Notification
Drugs
12/19/2013
Best Whips
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
12/19/2013
Asset Extreme
Various Distributors
n/a
assetcapsules4u.com
Undeclared sibutramine
Public Notification
Drugs
12/19/2013
7 Days Herbal Slim
Various Distributors
n/a
suncoastspaequipment.com
Undeclared sibutramine
Public Notification
Drugs
12/19/2013
Dr. Ming's Chinese Capsule
Various Distributors
n/a
slimbeautyusa.com
Undeclared sibutramine
Public Notification
Drugs
Warning Letter
12/19/2013
Sliming Diet Berry Plus
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
12/19/2013
Meizitang Citrus
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/29/2013
Hydravax
IQ Formulations
Sunrise, FL
n/a
Undeclared diuretic
Recall
Drugs
11/21/2013
Alpha Male
Various Distributors
n/a
n/a
Undeclared aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, dimethylsildenafil, and sildenafil
Public Notification
Drugs
11/21/2013
SlimExtra Herbal Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/21/2013
Body Beauty 5 Days Slimming Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/21/2013
Diet Master
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/21/2013
Super Slim
Various Distributors
n/a
bonanza.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
11/20/2013
Slim Max
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
11/19/2013
P-Boost
Tendex
Los Angeles, CA
n/a
Undeclared tadalafil
Recall
Drugs
11/19/2013
NatuRECT
Tendex
Los Angeles, CA
n/a
Undeclared tadalafil
Recall
Drugs
11/18/2013
RezzRX
Fossil Fuel Products, LLC
n/a
n/a
Undeclared hydroxylthiohomosildenafil and aminotadalafil
Recall
Drugs
11/16/2013
Rhino 5 Plus
Jobbers Wholesale
Paramount, CA
n/a
Undeclared desmethylcarbondenafil and dapoxetine
Recall
Drugs
11/16/2013
Maxtremezen
Jobbers Wholesale
Paramount, CA
n/a
Undeclared desmethylcarbondenafil and dapoxetine
Recall
Drugs
11/16/2013
Extenzone
Various Distributors
Paramount, CA
n/a
Undeclared desmethylcarbondenafil and dapoxetine
Recall
Drugs
11/14/2013
Adipotrim XT
Deseo Rebajar Inc.
n/a
deseorebajar.com
Undeclared fluoxetine
Recall
Drugs
11/08/2013
Vitalikor Fast Acting
Various Distributors
n/a
vitalityreseasrchlabs.com; vitalikor.com; gnc.com
Undeclared tadalafil and vardenafil
Public Notification
Drugs
11/07/2013
Jimpness Beauty Fat Loss Capsules
Various Distributors
n/a
jimpness.net
Undeclared ramine, phenolphthalein, and sildenafil
Public Notification
Drugs
11/05/2013
Goodliness Fat-Reducing Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/10/2013
Be Inspired
Various Distributors
n/a
beinspirednaturally.com
Undeclared sibutramine
Public Notification
Drugs
10/10/2013
Dr. Mao Slimming Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/10/2013
Perfect Body Solutions
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/10/2013
Bella Vi Insane Amp’d
Various Distributors
n/a
pureedgenutrition.com; newedgenutrition.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/10/2013
Bella Vi Amp’d Up
Various Distributors
n/a
pureedgenutrition.com; newedgenutrition.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/07/2013
Lidiy
B@B Trade, Inc
FL
lidiy.com
Undeclared sibutramine
Recall
Drugs
10/07/2013
Slim Fortune
B@B Trade, Inc
FL
slimfortune.com
Undeclared sibutramine
Recall
Drugs
10/07/2013
Slim Expert
B@B Trade, Inc
FL
slimexpert.com
Undeclared sibutramine
Recall
Drugs
09/24/2013
Virilis Pro
Haute Health, LLC
Williamstown, NJ
virilispro.com
Undeclared sildenafil
Recall
Drugs
09/24/2013
PHUK
Haute Health, LLC
Williamstown, NJ
virilispro.com
Undeclared sildenafil
Recall
Drugs
09/24/2013
Prolifta
Haute Health, LLC
Williamstown, NJ
virilispro.com
Undeclared sildenafil
Recall
Drugs
09/24/2013
XZen Xpress
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
09/24/2013
XZen 1200
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
09/24/2013
XZone Premium
Various Distributors
n/a
n/a
Undeclared sildenafil, tadalafil, and dapoxetine
Public Notification
Drugs
09/24/2013
Xzen Gold
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
09/24/2013
Wood-E
Various Distributors
n/a
netnutri.com
Undeclared sildenafil
Public Notification
Drugs
09/24/2013
Instant Slim, 收腹提臀果香型减肥胶囊, Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang, or Сокращать живот и повышать 3ад
Various Distributors
n/a
instantslim.org
Undeclared sibutramine
Public Notification
Drugs
08/27/2013
Pro Power Max
Hardmenstore.com
Fort Lauderdale, FL
n/a
Undeclared sildenafil
Recall
Drugs
08/27/2013
Evil Root
Hardmenstore.com
Fort Lauderdale, FL
n/a
Undeclared sildenafil
Recall
Drugs
08/27/2013
72HP
Hardmenstore.com
Fort Lauderdale, FL
n/a
Undeclared sildenafil
Recall
Drugs
08/22/2013
Ortiga
Various Distributors
n/a
ebay.com
Undeclared diclofenac
Public Notification
Drugs
08/07/2013
Tranquility
Health and Beyond, LLC
Boca Raton, FL
n/a
Undeclared doxepin and chlorpormazine
Recall
Drugs
08/05/2013
Quick Thin
Bethel Nutritional Consulting, Inc.
New York, NY
bethel30.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
08/05/2013
Bethel Advance
Bethel Nutritional Consulting, Inc.
New York, NY
bethel30.com
Undeclared sibutramine and phenolphthalein
Recall
Drugs
07/19/2013
Esbelin siloutte te
Herbal Give Care LLC
Grand Prairie, TX
n/a
Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine
Recall
Drugs
07/19/2013
Esbelin siloutte Herbal Blend with L-Carnitine
Herbal Give Care LLC
Grand Prairie, TX
n/a
Undeclared Ssbutramine, N-desmethylsibutramine, and N-di-desmethylsibutramine
Recall
Drugs
07/18/2013
Volcano Male Enhancement Liquid
Volcano Company
Long Beach, CA
n/a
Undeclared desmethyl carbodenafil, dimethylsildenafil, and dapoxetine
Recall
Drugs
07/18/2013
Volcano Male Enhancement Capsules
Volcano Company
Long Beach, CA
n/a
Undeclared desmethyl carbodenafil and dapoxetine
Recall
Drugs
06/28/2013
Clalis
Various Distributors
n/a
hardmenstore.com
Undeclared sildenafil
Public Notification
Drugs
06/28/2013
MaxTreme Zen
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
06/28/2013
Exten 1300
Various Distributors
n/a
n/a
Undeclared sildenafil and tadalafil
Public Notification
Drugs
06/28/2013
MVP Mega
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
06/27/2013
Meizi Evolution
Various Distributors
n/a
ebay.com
Undeclared sibutramine
Public Notification
Drugs
06/27/2013
Strawberry Balance
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
06/27/2013
Silver Sword
Various Distributors
n/a
hardmenstore.com
Undeclared sildenafil
Public Notification
Drugs
06/18/2013
Fat Zero
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
06/18/2013
Fruit & Plant Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
06/18/2013
Royal Dragon Herbal Tonic Balls
Various Distributors
n/a
n/a
Undeclared vardenafil
Public Notification
Drugs
06/18/2013
Extreme Body Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
06/18/2013
Paiyouji Plus
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
06/10/2013
Get It Up
Various Distributors
n/a
ebay.com
Undeclared sildenafil
Public Notification
Drugs
06/10/2013
Super Cheetah
Various Distributors
n/a
bonanza.com
Undeclared sildenafil
Public Notification
Drugs
06/10/2013
XIYOUJI QINGZHI CAPSULE
Various Distributors
n/a
jadera.net
Undeclared sibutramine
Public Notification
Drugs
06/10/2013
X Zen Platinum
Various Distributors
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
06/10/2013
Nights to Remember
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
06/10/2013
Cave Diver
Various Distributors
n/a
bonanza.com
Undeclared sildenafil
Public Notification
Drugs
06/10/2013
Reload
Various Distributors
n/a
reloadpill.com
Undeclared sildenafil
Public Notification
Drugs
06/10/2013
Bethel 30
Bethel Nutritional Consulting, Inc.
New York, NY
bethel30.com
Undeclared sibutramine
Public Notification
Drugs
Recall
Expanded Recall
06/10/2013
Mojo Risen
Various Distributors
n/a
ebay.com
Undeclared noracetildenafil
Public Notification
Drugs
05/07/2013
SexVoltz
BeaMonstar Products
Queen Creek, AZ
n/a
Undeclared tadalafil
Recall
Drugs
Expanded Recall
05/07/2013
Velextra
BeaMonstar Products
Queen Creek, AZ
n/a
Undeclared tadalafil
Recall
Drugs
05/07/2013
Amerect
BeaMonstar Products
Queen Creek, AZ
n/a
Undeclared tadalafil
Recall
Drugs
05/07/2013
Lightning Rod
Chang Kwung
n/a
n/a
Undeclared analogue of sildenafil
Recall
Drugs
05/07/2013
Bullet Proof
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
05/01/2013
Vicerex
American Lifestyle
640 Kreag Road, Pittsford, NY 14534
n/a
Undeclared tadalafil
Recall
Drugs
05/01/2013
Black Ant
American Lifestyle
640 Kreag Road, Pittsford, NY 14534
n/a
Undeclared sildenafil
Recall
Drugs
04/25/2013
Zoom-Zooma-Zoom
Amrutam Life Care Pvt. Ltd.
India
amrutamlifecare.com
Undeclared sildenafil
Public Notification
Drugs
Warning Letter
04/25/2013
Sex Plus
Various Distributors
n/a
n/a
Undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil
Public Notification
Drugs
04/11/2013
Affirm XL
Affirm XL, Inc
n/a
n/a
Undeclared analogue of sildenafil
Recall
Drugs
04/04/2013
MAXILOSS Weight Advanced Blue
Various Distributors
n/a
extremevitaminworld.com; dreamlifeweightloss.com
Undeclared sibutramine
Public Notification
Drugs
04/03/2013
Love Rider
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
04/03/2013
Ninja Mojo
Various Distributors
n/a
n/a
Undeclared tadalafil
Public Notification
Drugs
03/21/2013
Stiff Days
Various Distributors
n/a
stiffdays.com
Undeclared sildenafil
Public Notification
Drugs
03/21/2013
Libido Sexual Enhancer
Various Distributors
n/a
vegasredpleasure.com
Undeclared hydroxythiohomosildenafil, hydroxyhomosildenafil, sildenafil, and tadalafil
Public Notification
Drugs
03/12/2013
Night Bullet
Green Planet, Inc.
Riverside, CA
n/a
Undeclared sulfohydroxyhomosildenafil and aminotadalafil
Recall
Drugs
01/24/2013
Super Power
D&S Herbals, LLC, d/b/a Freedom Trading
Woodbridge, NJ
n/a
Undeclared sildenafil
Recall
Drugs
01/08/2013
MAXILOSS Weight Advanced
Various Distributors
n/a
dreamlifeweightloss.com
Undeclared sibutramine
Public Notification
Drugs
12/19/2012
WOW
Riger Naturals S.A.
n/a
gonepainfree.com; browerent.com; refumofanusa.com
Undeclared dexamethasone, diclofenac sodium and methocrabamol
Public Notification
Drugs
Consumer Update
12/19/2012
Slimdia Revolution
P&J Trading
n/a
pinkfatty.com
Undeclared sibutramine
Recall
Drugs
Public Notification
12/17/2012
Libigrow XXX
Performance Plus Marketing, Inc.
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Casanova
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Mojo Nights
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Mojo Nights Supreme
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Blue Diamond Platinum
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Libigrow
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
12/17/2012
Blue Diamond
Performance Plus Marketing, Inc
CA
n/a
Undeclared sulfoaildenafil and thioaidenafil
Recall
Drugs
11/08/2012
Best Share Green Coffee: Brazilian Slimming Coffee
Various Distributors
n/a
houseofmonet.com
Undeclared sibutramine
Public Notification
Drugs
11/08/2012
Beautiful Slim Body
Various Distributors
n/a
houseofmonet.com
Undeclared sibutramine
Public Notification
Drugs
11/08/2012
Japan Hokkaido Slimming Weight Loss Pills
Various Distributors
n/a
ebay.com
Undeclared sibutramine
Public Notification
Drugs
10/24/2012
Classic Zi Xiu Tang Bee Pollen
Zi Xiu Tang Success, LLC
Trexlertown, PA
n/a
Undeclared sibutramine
Recall
Drugs
10/24/2012
Ultimate Formula Capsules
Zi Xiu Tang Success, LLC
Trexlertown, PA
n/a
Undeclared sibutramine
Recall
Drugs
10/04/2012
Tianji True Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
09/12/2012
ACTRA-Sx 500
Body Basics Inc.
n/a
n/a
Undeclared sildenafil
Recall
Drugs
08/23/2012
Mojo Nights
Evol Nutrition Associates, Inc./Red Dawn
Kennesaw, GA
n/a
Undeclared tadalafil and sildenafil
Recall
Drugs
08/21/2012
Reumofan Plus Premium
Riger Naturals S.A.
n/a
n/a
Undeclared diclofenac sodium and methocarbamol
News Release
Drugs
Consumer Update
Recall
08/03/2012
Best Slim
CTV Best Group Inc.
Duluth, GA
bestslim.net
Undeclared sibutramine
Recall
Drugs
07/20/2012
X-Rock 3 Day Pill for Men
CRM Laboratories
Distributed by: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312; or MATE Enterprises, 1020 N. Venetian Drive, Miami, Florida 33139
xrockhim.com
Undeclared sildenafil and hydroxythiohomosildenafil
Recall
Drugs
07/20/2012
Z-Rock
CRM Laboratories
Distributed By: XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312
zrockusa.com
Undeclared sildenafil and hydroxythiohomosildenafil
Recall
Drugs
06/01/2012
Reumofan Plus
Riger Naturals S.A.
n/a
n/a
Undeclared dexamethasone, diclofenac sodium and methocarbamol
News Release
Drugs
Consumer Update
05/25/2012
Mojo Nights
Various Distirbutors
n/a
n/a
Undeclared sulfoaildenafil, sulfosildenafil, and hydroxythiohomosildenafil
Public Notification
Drugs
05/25/2012
Kaboom Action Strips
Various Distributors
n/a
kaboomformen.com
Undeclared sulfoaildenafil
Public Notification
Drugs
05/22/2012
EreXite
Various Distributors
n/a
amazon.com
Undeclared tadalafil
Public Notification
Drugs
05/18/2012
Libidron
West Coast Nutritionals, Ltd.
n/a
libidron.com; amazon.com
Undeclared tadalafil
Recall
Drugs
05/18/2012
Firminite
West Coast Nutritionals, Ltd.
n/a
firminite.com; amazon.com
Undeclared tadalafil
Recall
Drugs
05/18/2012
Extra Strength Instant Hot Rod
West Coast Nutritionals, Ltd.
n/a
instanthotrodextrastrength.com; amazon.com
Undeclared tadalafil
Recall
Drugs
05/16/2012
VMaxx Rx
Various Distributors
n/a
vmaxxrx.com
Undeclared sulfoaidenafil
Public Notification
Drugs
05/16/2012
Boost — Ultra Sexual Enhancement Formula
Various Distributors
n/a
boostultra.biz
Undeclared
Public Notification
Drugs
04/20/2012
ZenMaxx
Enhance Nutraceutical
Malaysia
zenmaxx.com
Undeclared aminotadalafil
Public Notification
Drugs
Warning Letter
04/20/2012
Instant Hard Rod
Enhance Nutraceutical
Malaysia
instanthardrod.com
Undeclared aminotadalafil
Public Notification
Drugs
Warning Letter
04/20/2012
RigiRx Plus
Enhance Nutraceutical
Malaysia
rigirxplus.com
Undeclared aminotadalafil
Public Notification
Drugs
Warning Letter
04/05/2012
African Black Ant
Various Distributors
n/a
ebay.com
Undeclared sildenafil and tadalafil
Public Notification
Drugs
04/05/2012
France T253
Various Distributors
n/a
ebay.com
Undeclared sildenafil
Public Notification
Drugs
04/03/2012
Japan Rapid Weight Loss Diet Pills Yellow
Xiushentang
n/a
ebay.com
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
04/03/2012
Japan Rapid Weight Loss Diet Pills Green
Xiushentang
n/a
ebay.com
Undeclared phenolphthalein
Public Notification
Drugs
02/22/2012
Mince Belle
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared sibutramine
Recall
Drugs
02/22/2012
Everlax
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared sibutramine
Recall
Drugs
02/22/2012
Ever Slim
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared sibutramine
Recall
Drugs
02/22/2012
Ever Slim Shake Mix
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared sibutramine
Recall
Drugs
02/22/2012
Acai-Man Mangosteen Herbal Drink
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared tadalafil
Recall
Drugs
02/22/2012
Perfect Men
Healthy People Co.
13105 Ramona Blvd Ste F, Irwindale, CA, 91706
n/a
Undeclared tadalafil
Recall
Drugs
02/18/2012
Japan Weight Loss Blue
Various Distributors
n/a
vitaminbestbuy.com
Undeclared sibutramine and ephedrine alkaloids
Public Notification
Drugs
02/18/2012
Man King
Various Distributors
n/a
vitaminbestbuy.com
Undeclared sildenafil
Public Notification
Drugs
02/18/2012
Hard Ten Days
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
02/10/2012
RegenArouse
Regeneca, Inc.
n/a
n/a
Undeclared tadalafil
Recall
Drugs
11/10/2011
Virility Max
Keime Inc dba Barry's Vitamins
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
10/18/2011
A-Slim 100% Natural Slimming Capsule
H&S GMP Factory
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Health Slimming Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Leisure 18 Slimming Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
P57 Hoodia
Huikng Pharmaceutical
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Magic Slim Weight Reduction Capsule
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Sheng Yuan Fang
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
PhentraBurn Slimming Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Tengda
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Acai Berry Soft Gel ABC
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Fruit Plant Lossing Fat Capsule
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Botanical Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Pai You Guo Slim Tea
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/18/2011
Lose Weight Coffee
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
DaiDaiHuaJiaoNang
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Public Notification
Drugs
10/18/2011
Advanced Slim 5
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Magic Slim Tea
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Ja Dera 100% Natural Weight Loss Supplement
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/18/2011
Slender Slim 11
Various Distributors
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
10/03/2011
Uprizing 2.0
Superior Metabolic Technologies Inc
Marietta, GA
n/a
Undeclared superdrol, a synthetic steroid
Recall
Drugs
07/08/2011
Meizitang Botanical Slimming 100% Natural Soft Gel
Intercharm Inc.
Fort Lauderdale, FL
n/a
Undeclared sibutramine
Public Notification
Drugs
Recall
07/08/2011
Slim Forte Slimming Coffee
Intercharm Inc.
Fort Lauderdale, FL
n/a
Undeclared sibutramine
Public Notification
Drugs
Recall
07/08/2011
Slim Forte Slimming Capsules
Intercharm Inc.
Fort Lauderdale, FL
n/a
Undeclared sibutramine
Public Notification
Drugs
Recall
07/08/2011
Slim Forte Slimming Capsule
LA Beauty Store, Inc.
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
07/08/2011
Slim Forte Double Power Slimming Capsules
LA Beauty Store, Inc.
n/a
n/a
Undeclared sibutramine
Public Notification
Drugs
05/29/2011
ViaXtreme
Various Distributors
n/a
n/a
Undeclared sulfoaildenafil
Public Notification
Drugs
05/10/2011
Slim Xtreme Herbal Slimming Capsule
Globe All Wellness, LLC
2854 Stirling Rd Suite G Hollywood, FL 33020
n/a
Undeclared sibutramine
Public Notification
Drugs
Recall
04/28/2011
Regenerect
Ethos Environmental, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
03/28/2011
THE BEST Enhancement Supplement
AVNS Inc
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
03/25/2011
Male Enhancer
USA Far Ocean Group Inc.
1609 W. Valley Blvd., #338, Alhambra, CA 91803
n/a
Undeclared tadalafil
Recall
Drugs
03/25/2011
X-Hero
USA Far Ocean Group Inc.
1609 W. Valley Blvd., #338, Alhambra, CA 91803
n/a
Undeclared sulfosildenafil
Recall
Drugs
03/22/2011
U-Prosta
USA Far Ocean Group Inc.
1609 W. Valley Blvd., #338, Alhambra, CA 91803
n/a
Undeclared terazosin
Recall
Drugs
03/16/2011
Black Ant
Various Distributors
n/a
n/a
Undeclared sildenafil
Public Notification
Drugs
02/24/2011
RegenErect
Regeneca, Inc.
n/a
n/a
Undeclared tadalafil
Recall
Drugs
02/22/2011
Extenze Tablets
Biotab Nutraceuticals, Inc.
n/a
n/a
Undeclared tadalafil and sildenafil
Recall
Drugs
News Release
02/11/2011
Svelte 30
Svelte 30 Nutritional Consultants
Kissimmee, FL
svelte.com
Undeclared sibutramine
Recall
Drugs
01/31/2011
Reduce Weight Fruta Planta
Godi International, Corp.
FL
n/a
Undeclared sibutramine
Recall
Drugs
01/31/2011
Fruta Planta
Godi International, Corp.
FL
n/a
Undeclared sibutramine
Recall
Drugs
01/18/2011
Nite Rider Maximum Sexual Enhancer For Men
Kanec USA Inc
n/a
n/a
Undeclared sildenafil
Recall
Drugs
01/18/2011
STUD Capsule for Men
Kanec USA Inc
n/a
n/a
Undeclared sildenafil
Recall
Drugs
01/12/2011
Celerite Slimming Capsules
Shaping Beauty, Inc.
Southampton, PA
celeriteweightloss.com; shapingbeauty.com
Undeclared sibutramine
Public Notification
Drugs
Recall
01/03/2011
Reduce Weight Fruta Planta
PRock Marketing LLC
N/A
frutaplanta.com
Undeclared sibutramine
Recall
Drugs
12/30/2010
Passion Coffee
Drive Total Energy
n/a
drivetotalenergy.com
Undeclared sulfoaildenafil
Public Notification
Drugs
12/30/2010
RockHard Extreme
Drive Total Energy
n/a
drivetotalenergy.com
Undeclared sulfoaildenafil
Public Notification
Drugs
12/22/2010
Fruta Planta
PRock Marketing LLC
n/a
frutaplanta.com
Undeclared sibutramine
Public Notification
Drugs
Recall
12/22/2010
Pandora
RockHard Laboratories
n/a
n/a
Undeclared analogue of Sildenafi
Recall
Drugs
12/22/2010
RockHard Weekend
RockHard Laboratories
n/a
n/a
Undeclared analogue of Sildenafi
Recall
Drugs
12/15/2010
Man Up Now
Synergy Distribution LLC
n/a
n/a
Undeclared sulfoaildenafil
News Release
Drugs
11/19/2010
Vigor-25
Piston Corp.
n/a
n/a
Undeclared sildenafil
News Release
Drugs
10/27/2010
Duro Extend Capsules For Men
Intelli Health Products
80 Southwest 8th Street Miami, FL 33130
n/a
Undeclared sulfoaidenafil
Recall
Drugs
Expanded Recall
10/08/2010
Slimming Beauty Bitter Orange Slimming Capsules
Beautiful Health Inc.
n/a
n/a
Undeclared sibutramine
News Release
Drugs
10/07/2010
Novedex XT
Gaspari Nutrition Incorproated
575 Prospect Street - Suite 230, Lakewood, NJ
n/a
Contains 3,17-keto-etiocholetriene, also known as ATD
News Release
Drugs
09/16/2010
Arom-X Capsules
Advanced Muscle Science
4590 Deodar St., Silver Springs, Nevada 89429
n/a
Contains 1,4,6 etioallocholan-dione, also known as ATD
Recall
Drugs
09/16/2010
Arom-X UTT Liquid
Advanced Muscle Science
4590 Deodar St., Silver Springs, Nevada 89429
n/a
Contains 1,4,6 etioallocholan-dione, also known as ATD
Recall
Drugs
09/16/2010
Arom-XL Liquid
Advanced Muscle Science
4590 Deodar St., Silver Springs, Nevada 89429
n/a
Contains 1,4,6 etioallocholan-dione, also known as ATD
Recall
Drugs
09/16/2010
4-AD Capsules
Advanced Muscle Science
4590 Deodar St., Silver Springs, Nevada 89429
n/a
Contains 1,4,6 etioallocholan-dione, also known as ATD
Recall
Drugs
09/16/2010
Decavol Capsules
Advanced Muscle Science
4590 Deodar St., Silver Springs, Nevada 89429
n/a
Contains 1,4,6 etioallocholan-dione, also known as ATD
Recall
Drugs
09/16/2010
Reversitol
Tribravus Enterprises, LLC d/b/a/ iForce Nutrition, LLC
1305 Hot Spring Way #103, Vista CA 92081
n/a
Contains 6-Etioallochol-1,4-Diene-3,17-Dione, also known as ATD
Recall
Drugs
09/15/2010
Off Cycle II Hardcore
Fizogen Precision Technologies
3133 Fortune Way, Suite #4, Wellington, FL 33414
n/a
Contains 3,17-keto-etiochol-triene, also known as ATD
Recall
Drugs
09/14/2010
Clomed
KiloSports Inc.
Phoenix, AZ
n/a
Undeclared aromatase inhibitor
Recall
Drugs
09/13/2010
ArimaDex
Genetic Edge Technologies
Phoenix, AZ
n/a
Undeclared aromatase inhibitor
News Release
Drugs
08/25/2010
TimeOut Capsules
Various Distributors
n/a
n/a
Undeclared hydroxythiohomosildenafil
News Release
Drugs
08/18/2010
Mr. Magic Male Enhancer from Don Wands
Glow Industries, Inc.
Perrysburg, OH
n/a
Undeclared hydroxythiohomosildenafil and sulfoaildenafil
Recall
Drugs
08/10/2010
Stiff Nights
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Aziffa
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Size Matters
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Erex
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Mojo
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Hard Drive
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Eyeful
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Red Magic
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Straight Up
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Zotrex
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Monster Excyte
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
WOW
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Xaitrex
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Verect
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Prolatis
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Xytamax
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Maxyte
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Libidinal
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
OMG
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
OMG45
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/10/2010
Zilex (with Golden Spear)
Novacare LLC
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/09/2010
Prolatis'
Prolatis'
Salt Lake City, UT
n/a
Undeclared sulfoaildenafil
Recall
Drugs
08/06/2010
Solo Slim®
EZVille, Ltd.
Ronkonkoma, NY
n/a
Undeclared didesmethyl sibutramine
Recall
Drugs
08/06/2010
Revivexxx® Extra Strength
EZVille, Ltd.
Ronkonkoma, NY
n/a
Undeclared tadalafil
Recall
Drugs
07/28/2010
Ejaculoid XXTREME
Nutraloid Labs Inc.
Kingston, NY
n/a
Undeclared sulfoaildenafil
Recall
Drugs
07/28/2010
Stimuloid II
Nutraloid Labs Inc.
Kingston, NY
n/a
Undeclared sulfoaildenafil
Recall
Drugs
07/22/2010
Joyful Slim Herb Supplement
J & H Besta Corp.
Hicksville, NY
n/a
Undeclared desmethyl sibutramine
Recall
Drugs
07/16/2010
Slim-30 Herb Supplement
J & H Besta Corp.
Hicksville, NY
n/a
Undeclared N-desmethyl sibutramine
Recall
Drugs
Expanded Recall
07/16/2010
Vialipro
Good Health, Inc.
Canutillo, TX
n/a
Undeclared sulfoaildenafil
Recall
Drugs
07/08/2010
Que She
Various Distributors
n/a
n/a
Undeclared fenfluramine, propanolol, sibutramine, ephedrine
Recall
Drugs
06/19/2010
Magic Power Coffee
INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC.
Brooklyn, NY
n/a
Undeclared hydroxythiohomosildenafil
News Release
Drugs
Recall
Consumer Update
06/04/2010
Rock Hard Weekend
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
On Cycle II Hardcore
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Sleep Quick Strips
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Sleep Once Again
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Sleep Ease
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Insomnix
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Musclextreme Pump Extreme
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
Derma-Tropin
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
06/04/2010
GH.X Growth Hormone Extreme
Atlas Operations, Inc.
325 Sw 15th Ave, Pompano Beach, FL 33069-3246
n/a
CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated
Warning Letter
Drugs
04/20/2010
Vitalex
Vitapro, Inc.
CA
n/a
Undeclared acetildenafil-analog
News Release
Drugs
04/12/2010
Amour Again for Him
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/12/2010
Erectzia
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/12/2010
Ere-xxx by Elite Body
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/12/2010
Ere-xxx by Maxi Elit
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/12/2010
Stamin It
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Warning Letter
04/12/2010
Vigor 100
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/12/2010
Whatz Up Rx
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
04/02/2010
Stud Capsule
Kanec USA Inc.
5061 South State Road 7. Ste 602, Davie FL 33314
n/a
Undeclared sildenafil
Recall
Drugs
03/30/2010
MasXtreme
Natural Wellness Inc.
440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441
n/a
Undeclared aildenafil and phentolamine; undeclared aminotadalafil
Recall
Drugs
Expanded Recall
01/15/2010
Advanced Muscle Science Dienedrone
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Advanced Muscle Science Liquidrone
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Anabolic Formulation M1, 4AD
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Anabolic Formulations 1, 4 AD
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Anabolic Xtreme Hyperdrol X2
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Anabolic Xtreme 3-AD
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
BCS Labs Testra-Flex
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Competitive Edge Labs M-Drol
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Competitive Edge Labs P-Plex
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Competitive Edge Labs X-Tren
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
4Ever Fit D-Drol
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Gaspari Novedex XT
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Gaspari Halodrol Liquigels
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
iForce 1,4 AD BOLD 200
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
iForce MethaDROL
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
iForce Dymethazine
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
01/15/2010
Monster Caps
MuscleMaster.com, Inc.
Northborough, MA
n/a
Contains steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
12/11/2009
Aspire One
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Warning Letter
12/11/2009
Sex Enhancer
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Staminil
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
Warning Letter
12/11/2009
Sexual Surge
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Love Fuel
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Vaxitrol
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Love Fuel 2
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Erexa
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Zenerect
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Arousin
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
72 Hours
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
Warning Letter
12/11/2009
Bulk- Unlabeled
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Enhancement
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Red Hot Sex
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Libiplus
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Erexxx
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Tacktol
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Amour for him
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Erousa
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Rockhard
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Ezerex
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Topviril
Atlas Operations, Inc.
Pompano Beach, FL
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Vierect
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
Warning Letter
12/11/2009
APL
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Clyamax
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Rainbow Rocket
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Finally On Demand
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
Warning Letter
12/11/2009
Xtremexcite
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
12/11/2009
Whatzup
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
12/11/2009
Depth Charge
Atlas Operations, Inc.
n/a
n/a
Undeclared sulfoaildenafil
Recall
Drugs
Expanded Recall
11/12/2009
Pai You Guo
GMP Herbal Products, Inc.
Westminster, CA
n/a
Undeclared sibutramine and phenolphthalein
Recall
Drugs
11/12/2009
Bromodrol
IDS Sports
n/a
n/a
Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
Recall
Drugs
11/12/2009
Dual Action Grow Tabs
IDS Sports
n/a
n/a
Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
Recall
Drugs
11/12/2009
Grow Tabs
IDS Sports
n/a
n/a
Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
Recall
Drugs
11/12/2009
Mass Tabs
IDS Sports
n/a
n/a
Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
Recall
Drugs
11/12/2009
Ripped Tabs TR
IDS Sports
n/a
n/a
Undeclared steroids, “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione”
Recall
Drugs
11/09/2009
RockHard Weekend
RockHard Laboratories
Atlanta, GA
n/a
Undeclared sulfoaildenfil
Recall
Drugs
11/03/2009
4Ever Fit D-Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Advanced Muscle Science Dienedrone
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Advanced Muscle Science Liquidrone UTT
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Anabolic Xtreme Hyperdrol X2
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
APS (aka Advanced Muscle Science) Mastavol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
APS (aka Advanced Muscle Science) Revamp
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
APS (aka Advanced Muscle Science) Ultra Mass Stack
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
APS (aka Advanced Muscle Science) Ripped Stack
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Better Body Sports Finadex
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Black China Labs Straight Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Black China Labs Straight Phlexed
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Body Conditioning Solutions TestraFLEX
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Bjorklund Methyldrostanolone
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
BOSC Enterprises Epi-Tren
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
BOSC Enterprises Magna Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Chaparral Labs Epivol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Chaparral Labs Pheravol-V
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Competitive Edge Labs M-Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Competitive Edge Labs P-Plex
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Competitive Edge Labs X-tren
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Diabolic Labs Epio-Plex
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Diabolic Labs Finabolic 50
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Diabolic Labs Revenge
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Ergopharm 6-OXO
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Ergopharm 6-OXO Extreme
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
EST (aka Engineered Sports Technology) MethAnstance
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Extreme Labs Susto-Test Depot
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Fizogen ON Cycle II Hardcore
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
G.E.T/ (Genetic Edge Technologies) SUS-500
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
News Release
11/03/2009
G.E.T/ (Genetic Edge Technologies) Tren-250
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Hardcore Formulations T-Roid
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Nutrition 1,4 AD Bold 200
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Dymethazine/Reversitol Combo Pack
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Reversitol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Nutrition 17a PheraFLEX
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Nutrition Dymethazine
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
I Force Nutrition Methadrol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
News Release
11/03/2009
IDS (aka Innovative Delivery Systems) Bromodrol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
IDS (aka Innovative Delivery Systems) Grow Tabs TR
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
IDS (aka Innovative Delivery Systems) Mass Tabs
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
IDS (aka Innovative Delivery Systems) Oxodrol Pro
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
IDS (aka Innovative Delivery Systems) Ripped Tabs TR
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
IDS (aka Innovative Delivery Systems) Rapid Release
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Ripped Tabs
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Kilo Sports Massdrol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Kilo Sports Phera-Mass
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Kilo Sports Trenadrol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids,, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Monster Caps Monster Caps
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Myogenix Spawn
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Nutra Coastal D-Stianozol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
News Release
11/03/2009
Nutra Coastal H-Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Nutra Coastal MDIT
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Nutra Coastal S-Drol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Nutra Coastal Trena
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Performance Anabolics Methastadrol
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Performance Anabolics Tri-Methyl X
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Purus Labs E-pol Inslinsified
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Purus Labs Nasty Mass
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Rage RV2
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Rage RV3
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Rage RV4
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Rage RV5
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
News Release
11/03/2009
Redefine Nutrition Finaflex 550-XD
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Redefine Nutrition Finaflex Ripped
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Transform Supplements Forged Extreme Mass
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
11/03/2009
Transform Supplements Forged Lean Mass
Bodybuilding.com, LLC
Boise, ID
bodybuiliding.com
May contain steroids, "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol"
Recall
Drugs
09/23/2009
Pineapple Fat Reducing Slimming Capsule
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Tomato Slimming (Lose Weight)
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Slim Up
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Fresh Lemon Slimming (Xian Ning Meng Shou Shen)
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Slim Quick Result 3 in 1
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Perfect Combination Balishou Capsule
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Apple Slim
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
09/23/2009
Shoufsy Activity Girl
Platinum Strategies Inc
1500 N, Curry Pike, Bloomington, IN 47404
911healthshop.com
Undeclared sibutramine; Labeling/Promotional Claims False & Misleading/New Drug/Misbranded
Warning Letter
Drugs
Close-out Letter
08/21/2009
STEAM
Nutracoastal Trading LLC
Freeport, NY
n/a
Undeclared tadalafil
Recall
Drugs
07/28/2009
S-DROL
Nutracoastal Trading LLC
Freeport, NY
n/a
Undeclared tadalafil
Recall
Drugs
07/27/2009
TREN-Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 19-Norandrosta-4,9-diene-3,17 diene; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
MASS Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 17α-methyl-etioallocholan-2-ene-17b-01; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
ESTRO Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 4-hydroxyandrostenedione (4-0HA); Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
AH-89-Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 5a-androstano[3,2-c]pyrazole-3-one-17B-01-THP-ether; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
HMG Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 2a,3a-epithio-17a-methyl-17~-hydroxy-5a-etioallocholane; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
MMA-3 Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains Androsta-1 ,4-dien-3, 17-dione; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
VNS-9 Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 17a-methyl-4-chloro-androsta-1,4-diene-3B, 17B-diol,1-androsteron; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/27/2009
TT-40-Xtreme
American Cellular Labs
117 Arcadia Drive, Pacifica, CA 94044
americell-labs.com
Contains 1-androsterone; Dietary Supplements/Adulterated/Misbranded
Warning Letter
Drugs
07/15/2009
LibieXtreme
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared aminotadafil
Recall
Drugs
07/15/2009
Y-4ever
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared sulfoaidenafil
Recall
Drugs
07/15/2009
Libimax X Liquid
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared aminotadafil
Recall
Drugs
07/15/2009
Powermania Liquid
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared sulfoaidenafil
Recall
Drugs
07/15/2009
Powermania Capsule
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared sulfoaidenafil
Recall
Drugs
07/15/2009
Herbal Disiac
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared sulfoaidenafil
Recall
Drugs
07/15/2009
One Weight Loss Pill
Young You Corporation
19590 Ventura Blvd., Tarzana, CA
n/a
Undeclared sibutramine
Recall
Drugs
07/15/2009
SlimDemand Capsules
Young You Corporation
19590 Ventura Blvd., Tarzana, CA
n/a
Undeclared sibutramine
Recall
Drugs
07/15/2009
Botanical Weight Loss
Young You Corporation
19590 Ventura Blvd., Tarzana, CA
n/a
Undeclared sibutramine
Recall
Drugs
07/13/2009
Libipower Plus
Haloteco
Los Angeles, CA
n/a
Undeclared tadalafil
Recall
Drugs
06/15/2009
Stamina-Rx
Hi-Tech Pharmaceuticals, Inc.
6015-B Unity Dr., Norcross, GA 30071
n/a
Undeclared benzamidenafil
Recall
Drugs
04/27/2009
Libimax
Opteron 1 Inc. dba Nature & Health Co.
Brea, CA
n/a
Undeclared tadalafil
Recall
Drugs
04/20/2009
Slim 3in1 M-18 ROYAL DIET
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
Extrim Plus 24 Hours RE-BURN Formula
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
Slim 3in1 EXTRA SLIM FORMULA
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
Slim 3in1 EXTRA SLIM WAIST FORMULA
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
Perfect Slim 100% Natural Herbal Essence
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
BODY SHAPING
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
SLIM FAST 2
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
SLIM FAST
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
SlimBurn
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
04/20/2009
TRIM PLUS 2
Universal ABC Beauty Supply International, Inc.
Brooklyn, NY
n/a
Undeclared sibutramine
Recall
Drugs
03/11/2009
Zencore Plus
Bodee LLC
Century City, CA
n/a
Undeclared benzamidenafil
Recall
Drugs
01/29/2009
Venom Hyperdrive 3.0
Applied Lifescience Research Industries Inc. (ALR Industries)
Oak View, CA
n/a
Undeclared sibutramine
News Release
Drugs
12/22/2008
2 Day Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
2 Day Diet Slim Advance
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
2x Powerful Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
3 Day Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
3 Days Fit
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
3x Slimming Power
Various Distributors
n/a
n/a
Undeclared sibutramine and phenytoin
Q&A
Drugs
Recall
12/22/2008
5x Imelda Perfect Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
7 Day Herbal Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
7 Days Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
7 Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
7 Diet Day/Night Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
8 Factor Diet
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
12/22/2008
Eight Factor Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
21 Double Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
24 Hours Diet
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
Recall
12/22/2008
999 Fitness Essence
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
BioEmagrecim
Various Distributors
n/a
n/a
Undeclared fenproporex; fluoxetine and furosemide
Q&A
Drugs
12/22/2008
Body Creator
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Body Shaping
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Body Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Cosmo Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Extrim Plus
Various Distributors
n/a
n/a
Undeclared sibutramine and phenytoin
Q&A
Drugs
12/22/2008
Extrim Plus 24 Hour Reburn
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Fasting Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Fatloss Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
12/22/2008
GMP
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Herbal Xenicol
Various Distributors
n/a
n/a
Undeclared cetilistat
Q&A
Drugs
12/22/2008
Imelda Fat Reducer
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Imelda Perfect Slim
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
Recall
12/22/2008
JM Fat Reducer
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Lida DaiDaihua
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Meili
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Meizitang
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Miaozi MeiMiaoQianZiJiaoNang
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Miaozi Slim Capsules
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Natural Model
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Perfect Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Perfect Slim 5x
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
12/22/2008
Perfect Slim Up
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Phyto Shape
Various Distributors
n/a
n/a
Undeclared rimonabant
Q&A
Drugs
12/22/2008
Powerful Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
ProSlim Plus
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Reduce Weihgt
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Royal Slimming Formula
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
Recall
12/22/2008
Sana Plus
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim 3 in 1
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim 3 in 1 Extra Slim Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim 3 in 1 Extra Slim Waist Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim 3 in 1 M18 Royal Diet
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim 3 in 1 Slim Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim Burn
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim Express 4 in 1
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Slim Express 360
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Slim Tech
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slim Up
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Slim Waist Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Slim Waistline
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Slimbionic
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Sliminate
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Slimming Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Somotrim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Starcaps
Various Distributors
n/a
n/a
Undeclared bumetanide
Q&A
Drugs
12/22/2008
Super Fat Burner
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Superslim
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
12/22/2008
Super Slimming
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
Recall
12/22/2008
Trim 2 Plus
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Triple Slim
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Venom Hyperdrive 3.0
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Waist Strength Formula
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Xsvelten
Various Distributors
n/a
n/a
Undeclared sibutramine
Q&A
Drugs
12/22/2008
Zhen de Shou
Various Distributors
n/a
n/a
Undeclared sibutramine and phenolphthalein
Q&A
Drugs
11/26/2008
STARCAPS DIET SYSTEM
Balanced Health Products, Inc.
n/a
n/a
Undeclared bumetanide
Recall
Drugs
Expanded Recall
11/23/2008
Zhen de Shou Fat Loss
Fashion Sanctuary
San Diego, CA
n/a
Undeclared sibutramine
Recall
Drugs
07/23/2008
Viapro
EG Labs, LLC
New York, NY
Undeclared thio-methisosildenafil
Recall
Drugs
07/01/2008
Rize 2 The Occasion
Jack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc
1501 Green Road Unit C Pompano Beach, FL
n/a
Undeclared thiomethisosildenafil
Recall
Drugs
Expanded Recall
07/01/2008
Rose 4 Her
Jack Distribution, LLC; G & N works, Inc.; Devine Distribution, Inc
1501 Green Road Unit C Pompano Beach, FL
n/a
Undeclared thiomethisosildenafil
Recall
Drugs
Expanded Recall
05/29/2008
Viril-Ity-Power (VIP) Tabs
International Pharmaceuticals, Ltd.
P.O. Box 5165, Bradford, MA 01835
n/a
Undeclared hydroxyhomosildenafil
Recall
Drugs
05/27/2008
Xiadafil VIP Tabs
SEI Pharmaceuticals
Miami, FL
n/a
Undeclared hydroxyhomosildenafil
News Release
Drugs
03/31/2008
Maxidus
KG Enterprises LLC
PO Box 5156, El Dorado Hills, CA 95742
n/a
Undeclared sildenafil and tadalafil
Recall
Drugs
03/25/2008
Blue Steel
Active Nutraceuticals; Marion Group
Carrollton, GA
n/a
Undeclared substances that are similar in chemical structure to sildenafil
News Release
Drugs
03/25/2008
Hero
Active Nutraceuticals; Marion Group
Carrollton, GA
n/a
Undeclared substances that are similar in chemical structure to sildenafil
News Release
Drugs
02/28/2008
Aspire36
Palo Alto Labs
265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984
n/a
Undeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)
Recall
Drugs
02/28/2008
Aspire Lite
Palo Alto Labs
265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984
n/a
Undeclared aildenafil and dimethyl sildenafil thione (sulfoaildenafil)
Recall
Drugs
12/28/2007
Super Shangai
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Strong Testis
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Shangai Ultra
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Shangai Ultra X
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Lady Shangai
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Shangai Regular (Shangai Chaojimengnan)
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared sildenafil analogues
Recall
Drugs
12/28/2007
Naturalë Super Plus
Shangai Distributor, Inc.
Coamo, Puerto Rico
n/a
Undeclared APIs for erectile dysfunction
Consumer Update
Drugs
11/21/2007
Encore Tabs
Bodee LLC
Avenue of the Stars, 702E, Century City, CA 90067
n/a
Undeclared aminotadalafil
Recall
Drugs
09/12/2007
Axcil
TWC Global, LLC
530 Showers Drive, Suite 7-129, Mountain View, CA 94040
n/a
Undeclared sildenafil, sulfosildenafil and sulfohomosildenafil
Recall
Drugs
09/12/2007
Desirin
TWC Global, LLC
530 Showers Drive, Suite 7-129, Mountain View, CA 94040
n/a
Undeclared sildenafil, sulfosildenafil and sulfohomosildenafil
Recall
Drugs
08/31/2007
Zencore Tabs
Bodee LLC
Avenue of the Stars, 702E, Century City, CA 90067
n/a
Undeclared aminotadalafil, sulfosildenafil, sulfohomosildenafil
Recall
Drugs
08/17/2007
METABOSLIMTM Apple Cider Vinegar
Confidence Inc.
Port Washington, NY
n/a
Undeclared sibutramine
Recall
Drugs
06/14/2007
Long Weekend
Confidence Inc.
Port Washington, NY
n/a
Undeclared tadalafil
Recall
Drugs
04/17/2007
H S Joy of Love
Jen-On Herbal Science International, Inc.
205 Russell St., City of Industry, CA 91744
n/a
Undeclared piperadino vardenafil
Recall
Drugs
03/16/2007
Rhino Max (Rhino V Max)
Cosmos Trading, Inc.
543 Olympic Blvd, Suite # 419, Los Angeles, CA 90015
n/a
Undeclared aminotadalafil
Safety Alert
Drugs
Recall
Product name linked to image when available.
*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.
Content current as of:
04/22/2026
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