FDA updates on hand sanitizers consumers should not use | FDA

FDA updates on hand sanitizers consumers should not use | FDA
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FDA updates on hand sanitizers consumers should not use
Drug Alerts and Statements
In this section
This page is no longer being updated. Visit the
drug recalls
page or search FDA’s
recalls database
for additional hand sanitizer recalls. You also can find information on inspections and other FDA actions on the
data dashboard
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Hand sanitizers consumers should not use
FDA urges consumers not to use certain hand sanitizer products
One of the best ways to prevent the spread of COVID-19 or other diseases are to wash your hands with soap and water. If soap and water are not available, the Centers for Disease Control and Prevention recommends using an alcohol-based hand sanitizer that contains at least 60% ethanol (also known as ethyl alcohol).
Visit
Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
and
Safely Using Hand Sanitizer
for more information.
How to identify hand sanitizer products you should not use:
The names of the specific
manufacturers
NDC
number, which may also be located on the product label.
The name of the
distributors
that sell, or sold or had planned to sell specific hand sanitizers
products
produced by these manufacturers.
If the manufacturer is not listed on the label, contact the distributor to find out who manufactured the product. If the distributor refuses to clarify this information when you contact them, FDA recommends you do not use the product.
FDA recognizes that distributors may use more than one manufacturer to produce their hand sanitizer products even if they are marketed under the same brand name. FDA’s recommendation not to use a manufacturer specific hand sanitizer would not necessarily extend to all products under that specific distributor brand name or other products sold by that distributor.
How to use the table below:
Using the information on the hand sanitizer label, type one of the following in the search box:
Product or brand name
Manufacturer, or the company that produced the product (may not be included on the product label)
Distributor, the company that brings the product to market
NDC or National Drug Code number (may not be included on the product label)
Do not use any hand sanitizer made by manufacturers on the list.
Manufacturer
Product(s)
NDC(s)
Distributor
Product Status
Date added to table
Aruba Aloe Balm Inc. (Aruba)
Aruba Aloe Hand Sanitizer 80% Alcohol
53675-185-12
53675-192-02
Aruba Aloe of North America LLC (Indiana)
Product contains methanol based on information provided by the manufacturer; product voluntarily
recalled
on 4/5/2024
04/17/2024
Aruba Aloe Balm Inc. (Aruba)
Aruba Aloe Hand Sanitizer Spray 80% Alcohol
53675-193-02
53675-193-08
Aruba Aloe of North America LLC (Indiana)
Product contains methanol based on information provided by the manufacturer; product voluntarily
recalled
on 4/5/2024
04/17/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Shierjie
43116-001-01
43116-001-02
43116-001-03
43116-001-04
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol rinse free hand sanitizer Shierjie
43116-002-01
43116-002-02
43116-002-03
43116-002-04
43116-002-05
43116-002-06
43116-002-07
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Medical Alcohol Wipes
43116-003-01
43116-003-02
43116-003-03
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie 75% Alcohol Wipes
43116-020-01
43116-020-02
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Disinfecting Soft Wipes
43116-026-01
43116-026-02
43116-026-03
43116-026-04
43116-026-05
43116-026-06
43116-026-07
43116-026-08
43116-026-09
43116-026-10
43116-026-11
43116-026-12
43116-026-13
43116-026-14
43116-026-15
43116-027-02
43116-004-02
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Salusen Premium 75% Alcohol Disinfectant Wipes
43116-006-01
43116-006-02
43116-006-03
43116-006-04
Procom Products Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Alcohol pads One pad saturated with 75% alcohol
43116-016-01
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Natural Aloe Advanced Hand Sanitizer
43116-007-01
WBM USA (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Advanced Hand Sanitizer Natural Aloe
43116-008-01
43116-008-02
WBM USA (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
WBM Care Advanced Hand Sanitizer Lemon & Orange
43116-009-01
WBM USA (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XEPA Antibacterial Hand Wipes
43116-010-01
Apex Enterprise Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Hand Sanitizer Gel
43116-015-01
43116-015-02
43116-015-03
43116-015-04
43116-015-05
43116-015-06
43116-015-07
43116-015-08
43116-015-09
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Shierjie Alcohol Wipes
43116-018-01
43116-018-02
43116-018-03
43116-018-04
43116-018-05
43116-018-06
43116-018-07
43116-018-08
43116-018-09
43116-018-10
43116-018-11
43116-018-12
43116-018-13
43116-018-14
43116-018-15
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
75% Alcohol Antibacterial Hand Wipes
43116-021-02
Grocery Outlet Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Necessities Antibacterial Wipes Aloe Vera
43116-021-01
PK Douglass (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XS Alcohol Prep Pad
43116-022-01
43116-023-01
80015-434-01
XS-Supply (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
XS Wipes 75% Alcohol Wipes
43116-025-01
XS-Supply (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Alcohol Antiseptic Hand Sanitizer Antibacterial
43116-030-01
Custom Quest (Ohio)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Shenzhen Shierjie Biological Engineering Co. Ltd. (China)
Viloe 75% Alcohol Hand Sanitizer Wipes
43116-281-40
Sonora Corp. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Lydia Co. Ltd. (Korea)
Hand & Care Clear Gel
72988-0024-1
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 3/5/2024
02/21/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Kentex Instant Hand Sanitizer with Aloe Vera
69556-333-02
69556-333-08
69556-333-16
69556-333-32
Kentron Healthcare, Inc. (Tennessee)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Kentex Hand Sanitizing Wet Wipes
69556-444-80
Kentron Healthcare, Inc. (Tennessee)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Medical Mary Clean Hand Gel Sanitizer
73027-101-06
73027-101-12
73027-101-30
73027-101-50
Medical Mary, LLC (Michigan)
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Jiangsu Hanhe Daily Chemicals Co., Ltd. (China)
Fresh Basics + Disinfectant Gel
73027-106-01
73027-106-02
80550-002-01
80550-002-02
3B International LLC
Product manufactured at a facility that did not respond to multiple notice of inspection requests from FDA related to drug manufacturing and product quality.
01/10/2024
Hygienic Labs, LLC.
(Iowa)
KleenSwell Liquid Hand Sanitizer
79692-002-01
79692-002-05
79692-002-50
Hygienic Labs, LLC.
(Iowa)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality  even after receiving a warning letter. FDA issued
warning letter
on 9/19/2023.
11/08/2023
Hygienic Labs, LLC.
(Iowa)
KleenSwell Gel Hand Sanitizer with Aloe
79692-003-01
79692-003-08
79692-003-05
79692-003-16
79692-003-50
Hygienic Labs, LLC.
(Iowa)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality  even after receiving a warning letter. FDA issued
warning letter
on 9/19/2023.
11/08//2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Advanced Formula Hand Sanitizer
74955-020-17
74955-020-18
74955-020-33
74955-020-84
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Soft & Gentle Antibacterial Wet Wipes
74955-021-01
74955-021-02
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Hand Cleaning Spray Antibacterial Hand Sanitizer
74955-022-05
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Alcohol Wipes Containing 70% Antibacterial Plus Hygiene
74955-027-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Antibacterial Wipes with Alcohol
74955-028-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft Multipurpose Sanitizing Wipes
74955-029-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Berry Fresh Scent
74955-034-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Citrus Fresh Scent
74955-035-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Crisp Linen Fresh
74955-036-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Breeze Extra Soft 75% Alcohol Sanitizing Spray Ocean Fresh Scent
74955-037-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Natural Sense 75% Alcohol Wipes Lemon Scent
74955-038-02
78440-002-01
78440-002-02
78440-002-03
IGT Group (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Quick Protect Sanitizing Spray Linen Fresh
74955-039-02
80702-039-02
Premier Wholesale (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
(Turkey)
Naturally Antibacterial Wet Wipes Formulated to Include Aloe Vera
74955-040-01
UNAC International Inc.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/08/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Original
52862-606-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Cucumber Melon
52862-607-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Sweet Pea
52862-608-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Lavender
52862-609-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Instant Hand Sanitizer with Aloe Vera & Vitamin E Peach
52862-610-08
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Health Smart Wet Wipes Antibacterial for Hands & Face
52862-611-10
52862-611-30
52862-611-40
52862-611-50
52862-611-00
52862-613-01
52862-613-02
78564-613-01
78564-613-02
Homesmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Germ Out Fresh Scent Antibacterial Wet Wipes
72308-015-20
72308-015-60
72308-025-20
72308-025-60
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Blue Sage Lime
72308-036-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Strawberry Tart
72308-037-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Visibly Clean Antibacterial Wet Wipes Fresh Lemonade
72308-038-00
Flex Beauty Labs, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Wet Wipes
78564-000-01
78564-000-02
78564-000-03
78564-000-04
78564-000-05
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Hand Gel
78564-001-01
78564-001-02
78564-001-03
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Anti-Bacterial Hygienic Hand Cleaning Liquid
78564-003-01
78564-003-02
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Bittol Alcohol Wipes
78564-004-01
78564-004-02
78564-004-03
78564-004-04
78564-004-05
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Ten Wet Wipes Antibacterial for Hands & Face
78564-006-10
COSCA Inc (Puerto Rico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi
(Turkey)
Antibacterial Colmerg Hand Sanitizing Wipes
80171-001-00
80171-002-00
Colmerg Products LLC (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/24/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Rosemary and Peppermint Hand Sanitizer
76473-100-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Orange and Peppermint Hand Sanitizer
76473-101-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Lemongrass and Peppermint Hand Sanitizer
76473-102-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Lavender and Peppermint Hand Sanitizer
76473-103-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/12/2023.
11/01/2023
Gulf States International, Inc.
(Alabama)
Brittanie’s Thyme Gel Hand Sanitizer​
76473-104-01
Brittanie’s Thyme, LLC (Alabama)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/12/2023.
11/01/2023
Maison Blanche LLC (Texas)
Hand Sanitizer N°93 Maison Blanche Eucalyptus & Coconut Oil
78966-111-11
78966-111-12
78966-111-13
Maison Blanche LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/14/2023.
10/11/2023
WIPRO Consumer Care Vietnam Co. Ltd. (Vietnam)
Aiken Hand Sanitizer
75651-172-01
75651-172-02
75651-172-22
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-001-02
71490-001-03
71490-002-02
71490-002-03
71490-003-02
71490-003-03
71490-004-02
71490-004-03
71490-005-02
71490-005-03
71490-006-02
71490-006-03
71490-007-02
71490-007-03
71490-008-02
71490-008-03
71490-009-02
71490-009-03
71490-010-02
71490-010-03
71490-011-02
71490-011-03
71490-012-02
71490-012-03
71490-013-02
71490-013-03
71490-014-02
71490-014-03
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-015-03
71490-016-03
71490-017-03
71490-018-03
71490-019-03
71490-020-03
71490-021-03
71490-022-03
71490-023-03
71490-024-03
71490-025-03
71490-026-03
71490-027-03
71490-028-03
71490-030-03
71490-031-05
71490-032-03
71490-032-05
71490-033-03
71490-033-05
71490-034-03
71490-034-05
71490-035-03
71490-035-05
71490-036-05
71490-037-03
71490-037-05
71490-038-05
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Gold Antiseptic Hand Sanitizer Gel with Vitamin Beads
71490-029-03
71490-030-03
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hand Sanitizer Gel
71490-039-01
71490-039-07
71490-040-01
71490-040-07
71490-041-01
71490-041-04
71490-041-07
71490-042-04
71490-059-01
71490-059-07
71490-059-08
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Sukhtian Households and Toiletries Manufacturing Co. Ltd. (Jordan)
HiGeen Antiseptic Hands & Things Sanitizer Spray
71490-043-08
71490-043-09
71490-043-13
71490-044-09
71490-045-08
71490-045-09
71490-045-13
71490-046-08
71490-046-09
71490-046-13
71490-047-08
71490-047-09
71490-047-13
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
GTP International Corp. (Texas)
Green Beauty Advanced Hand Sanitizer
79347-000-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 08/30/2023.
08/30/2023
Cergomex Imports, LLC (Texas)
Sanetto Hands Sanitizer Gel
81101-200-02
81101-200-03
81101-200-04
Cergomex Imports, LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 08/04/2023.
08/30/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
First Safety Instant Hand Sanitizer Wipes (70% Alcohol)
74763-002-01
74763-002-02
74763-002-03
74763-002-04
76720-002-01
76720-002-02
76720-002-03
76720-002-04
76720-002-05
76720-002-06
First Safety (Massachusetts)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Responsible Hand Sanitizer Advanced Moisturizing Formula With Vitamin E
(70% Alcohol)
74763-003-01
74763-003-02
74763-003-03
76720-003-01
76720-003-02
76720-003-03
Clover Imaging Group (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
OmegaClean Alcohol Wipes
74763-005-01
74763-005-02
74763-005-03
JAS Supply (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
First Safety Instant Hand Sanitizer Wipes (75% Alcohol)
74763-013-01
74763-013-02
76720-013-01
76720-013-02
76720-013-03
76720-013-04
76720-013-05
First Safety (Massachusetts)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
AltruFuel Sanitizer Wipes (75% Alcohol)
74763-014-01
74763-015-01
75421-002-00
75421-002-01
75421-002-02
Altrufuel dba Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Miami Carry On Disinfecting & Sanitizing 75% Alcohol Wipes
74763-018-01
74763-018-02
74763-018-03
74763-018-04
74763-018-05
Naftali Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
M Antibacterial Hand Gel Packs
74763-019-01
74763-019-11
Mytagalongs (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
DefendMax Hand Sanitizer (75% Alcohol)
78256-102-01
78256-102-02
78256-102-08
78256-102-16
78256-102-32
78256-102-64
DefendMax (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
PuraHands Hand Sanitizer
78256-104-02
78256-104-08
78256-104-16
PuraHands (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Miami Carry On Instant Hand Sanitizer With Vitamin E
74763-012-01
74763-012-02
74763-012-03
74763-012-04
Naftali Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Gafle Hand Sanitizer Gel with moisturizer
74763-001-01
74763-001-02
74763-001-03
74763-001-04
74763-001-05
Zhejiang Gafle Auto Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi
(Turkey)
ALLPURE Hand Sanitizer with Soothing Aloe Vera Natural 70% Alcohol
78575-002-01
78575-002-02
78575-002-03
78575-002-04
78575-002-05
78575-002-06
78575-002-07
CERCI USA Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Yesililgaz Kozmetik Kimya Insaat Otomotiv Ve Gida Sanayi
(Turkey)
DEVANIT Hand Sanitizer Natural 70% Alcohol Antiseptic with Soothing Aloe Vera
78575-001-01
78575-001-02
78575-001-03
78575-001-04
78575-001-05
78575-001-06
CERCI USA Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Planet Luxe Operations Pty, Ltd.
(Australia)
Planet Luxe Hand Sanitizer
81109-000-50
81109-001-50
Planet Luxe Operations Pty, Ltd. (Australia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Absolut Distillers, Ltd.
(Philippines)
ALCOGENIX Alcohol
Antiseptic 80% Topical Solution Hand Sanitizer
90046-503-01
90047-503-01
Midway Trading Corporation (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Myxx Antibacterial Hand Sanitizer
72619-2020-1
72619-2020-2
72619-2020-4
77969-004-01
77969-004-02
Accessory Myxx LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
Import alert
to help stop their products from entering the U.S. on 09/14/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Hand Sanitizer Contains 70% Ethyl Alcohol Topical Solution
75624-123-01
75624-123-02
75624-123-03
75624-123-04
75624-123-05
75624-123-06
SCAASIS/Oceanic Trading (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/14/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Lovemee Hand Sanitizer
77969-001-01
77969-001-02
77969-001-04
77969-001-05
77969-001-06
77969-001-07
77969-001-08
77969-001-09
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Doc Hygiene Hand Sanitizer Spray
77969-003-01
Doc Hygiene
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Leads China Biotech Co., Ltd.
(China)
Doc Hygiene Hand Sanitizer Extra Strength
77969-002-01
77969-002-02
78765-001-01
79508-010-01
79508-010-02
79508-010-03
Doc Hygiene
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/15/2023.
08/23/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
Antibacterial Hand Wipes
(75% Alcohol)
77765-000-01
77765-000-02
77765-000-03
79188-000-01
79188-000-02
79188-000-03
Sam Hedaya Corp. (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
Pura Wipes (75% Alcohol)
77765-001-00
79300-001-00
Zaappaaz LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
XcellaClean 75% Alcohol Disinfectant Wipes
77765-012-01
77765-012-02
77765-012-03
77765-012-04
77765-012-05
77765-012-06
77765-012-07
77765-012-08
77765-012-09
77765-012-10
77765-012-11
77765-012-12
77765-012-13
77765-012-14
77765-012-15
77765-012-16
77765-012-17
77765-012-18
Ningbo Unice Houseware Co., Ltd (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
XcellaClean Mild antibacterial formula Disinfectant Wipes
77765-013-01
77765-013-02
77765-013-03
77765-013-04
77765-013-05
77765-013-06
77765-013-07
77765-013-08
77765-013-09
77765-013-10
77765-013-11
77765-013-12
77765-013-13
77765-013-14
77765-013-15
77765-013-16
77765-013-17
77765-013-18
Ningbo Unice Houseware Co., Ltd (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes Ethyl Alcohol 75%
77765-014-01
OlleyMay (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wet Wipes
77765-015-01
Carity USA LLC (Delaware)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes Ethyl Alcohol 75%
77765-011-01
77765-011-02
77765-011-03
77765-011-04
77765-011-05
77765-011-06
77765-011-07
77765-011-08
77765-011-10
77765-021-01
77765-021-02
77765-021-03
77765-021-04
77765-021-05
77765-021-06
77765-021-07
77765-021-08
77765-021-09
77765-021-10
Candy Brush LLC (Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes 75% Ethyl Alcohol
78198-004-01
78198-004-02
Creative Home Ideas (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Hangzhou Beitai Daily Commodity Co., Ltd.
(China)
DailyGard Wipes 75% Isopropyl Alcohol
78198-005-01
78198-005-02
Creative Home Ideas (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/06/2023.
08/16/2023
Amata Life Plus Co., Ltd.
(Thailand)
Clean Day Antiseptic
(70% Alcohol)
80167-070-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/31/2023.
08/16/2023
Prenger Furniture Inc.
(Iowa)
PFI Hand Sanitizer 80% Alcohol
74667-001-01
Unknown
FDA tested product; contains unacceptable level of acetal and acetaldehyde contaminants; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer
79492-000-01
In & Out Products & Services (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Gelim Alcohol Antiseptic Topical Gel 80% Hand Sanitizer
79492-000-02
79492-000-03
79492-000-04
79492-000-05
79492-000-06
79492-000-07
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Ethyl 80% Alcohol Solution (Ethyl Alcohol 80%)
79492-001-01
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality
08/02/2023
Farmacos Bioequivalentes, S.A., dba: Biopharma
(Nicaragua)
Isopropyl Alcohol (ANTI-INFECTIVE, TOPICAL) Hand Sanitizer
Unable to determine
Unknown
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
08/02/2023
Penseur Kreativa Group
(Dominican Republic)
CARE HAND
Antibacterial
Desinfectante De Manos (Isopropyl Alcohol 70%)
81227-000-01
81227-000-02
81227-000-03
81227-000-04
81227-000-05
81227-000-06
81227-000-07
81227-000-08
81227-000-09
Penseur Kreativa Group
(Dominican Republic)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
PENSEUR GROUP
Alcohol Isopropilico (Isopropyl Alcohol 70%)
81227-002-00
81227-002-01
81227-002-02
81227-002-03
81227-002-04
Penseur Kreativa Group
(Dominican Republic)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
GO GERMS OUT
Antiseptic (Isopropyl Alcohol 70%)
81227-001-00
81227-001-01
81227-001-02
81227-001-03
81227-004-00
81227-004-01
81227-004-02
81227-004-03
81227-004-04
Penseur
Products Group LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/05/2023
Penseur Kreativa Group
(Dominican Republic)
VPBIOMED Antiseptic
Hand Sanitizer (Isopropyl Alcohol 70%)
81227-008-00
81227-008-01
81227-008-02
81227-008-03
81227-009-00
81227-009-01
81227-009-02
81227-010-00
81227-010-02
81227-010-02
Paola Enterprises para
VP Biomed LLC (Puerto Rico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
07/
05/2023
Beattie’s Distillers Inc
(Canada)
Beattie’s Distillers Hand Sanitizer
77427-7427-7
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Beattie’s Distillers Inc
(Canada)
Beattie’s Distillers Hand Sanitizer Liquid 80% Alcohol
77427-7444-4
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Beattie’s Distillers Inc
(Canada)
Beattie’s Distillers Hand Sanitizer Gel Formula
77427-6311-5
Beattie’s Distillers Inc
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Absolved Hand Sanitizer
75600-807-01
75600-807-04
75600-807-10
75600-807-12
75600-807-25
75600-807-27
75600-807-55
Not listed
FDA tested product; contains unacceptable level of acetal contaminant; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Absolved Hand Sanitizer
75600-807-50
Entral Product Solutions (California)
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Classic Wine Vinegar Company, Inc.
(California)
Hand Sanitizer Liquid
79117-070-01
79117-070-55
79117-070-99
Emerge Technologies, Inc. (Texas)
Product purported to be made at the same facility that produced an acetal contaminated product; Product manufactured at a facility that did not respond to multiple FDA requests for information related to drug manufacturing, product quality, and the scope of the contamination
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Sierra Soft Alcohol hand sanitizer
70415-002-01
70415-100-01
76591-109-01
Sierra Health Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Royal 70% Alcohol Foam Hand Sanitizer
70415-202-01
76591-108-01
Royal Papers, Inc.
(Missouri)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Fresh Hand Foaming Hand Sanitizer Alcohol Foam
70415-203-11
76591-104-11
Resource Solutions of SF Group, Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Hand Hygiene Puro 70% Alcohol Foaming Hand Sanitizer
70415-402-01
76591-105-01
Sierra Health, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Delicare Alcohol Hand Sanitizer
70415-601-11
76591-103-11
76591-106-11
SML Medical Supplies, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
HYTN Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer
74871-052-00
74871-052-01
74871-062-00
74871-062-01
74871-101-00
74871-101-01
74871-238-00
74871-238-01
74871-501-00
74871-902-00
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
PPE 361 Hand Sanitizer with Aloe Vera Extract Vitamin E & Moisturizer
74871-053-00
74871-063-00
74871-102-00
74871-239-00
74871-502-00
74871-903-00
76591-102-01
76591-102-02
76591-102-03
76591-102-04
76591-102-05
76591-102-06
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
HYTN 75% Alcohol Multipurpose Wipes
74871-081-00
iTech361 LLC (New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Raw Instant Hand Sanitizer Gel
75353-614-50
The Raw Office Inc. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Altrufuel advanced formula With Aloe Vera Hand Sanitizer
75421-000-00
75421-000-01
Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Altrufuel advanced formula With Vitamin E + Aloe Vera Hand Sanitizer
75421-001-00
75421-001-01
Mad Dog Concepts, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Physicians Wellness Products Hand Sanitizer Alcohol Antispetic 75%
76591-001-01
76591-001-02
79242-001-01
79242-001-02
Physician’s Wellness Group Inc (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Rinse-free Hand Sanitizer
76591-101-01
76591-101-02
76591-101-03
76591-101-04
76591-101-05
76591-101-06
76591-101-07
76591-101-08
76591-101-09
76591-101-10
76591-101-11
76591-101-12
76591-101-13
76591-101-14
76591-101-15
76591-101-16
76591-101-17
76591-101-18
76591-101-19
76591-101-20
76591-101-21
76591-101-22
76591-101-23
76591-101-24
76591-101-25
76591-101-26
76591-101-27
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer
76591-201-01
76591-201-02
76591-201-03
76591-201-04
76591-201-05
76591-201-06
76591-201-07
76591-201-08
76591-201-09
76591-201-10
76591-201-11
76591-201-12
76591-201-13
76591-201-14
76591-201-15
76591-201-16
76591-201-17
76591-201-18
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.9% Disposable Alcohol Sanitizer
76591-301-01
76591-301-02
76591-301-03
76591-301-04
76591-301-05
76591-301-06
76591-301-07
76591-301-08
76591-301-09
76591-301-10
76591-301-11
76591-301-12
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Gel Alcohol Hand Sanitizer
76591-401-01
76591-401-02
76591-401-03
76591-401-04
76591-401-05
76591-401-06
76591-401-07
76591-401-08
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Halloween Party Favors Hand Sanitizer
76591-402-01
Walmart Inc. (Arkansas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Spray Alcohol Hand Sanitizer
76591-501-01
76591-501-02
76591-501-03
76591-501-04
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Gotdya Bacteriostatic Rate 99.99% Disposable Alcohol 75% Alcohol Antiseptic Wipes
76591-601-01
76591-601-02
76591-601-03
76591-601-04
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
CenterWell Bacteriostatic Rate 99.9% Spray Alcohol Hand Sanitizer
76591-701-01
Guangzhou Gotdya Fine Chemical Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Maxda Care Alcohol Gel Hand Sanitizer
76591-801-01
Vertriebs GmbH (Germany)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
LIFEMEDZ Hand Sanitizer
78500-100-30
LIFEMEDZ LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
LIFEMEDZ Rinse-Free Hand Sanitizer
78500-101-30
78500-101-38
78500-101-50
LIFEMEDZ LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Miracle Brands Touchless Dispenser Hand Sanitizer
80352-001-01
Miracle Brands, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Miracle Brands Hand Sanitizer Refill Bottle
80352-002-01
Miracle Brands, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Sanibeads Hand Sanitizer Filled Bracelet
80627-001-01
Sanibeads, LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
Guangzhou Gotdya Fine Chemical Co., Ltd.
(China)
Tego Systems Professional Grade Hand Sanitizer
81497-700-01
81497-701-01
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/21/2023
IBC Business COOP
(South Korea)
Young Living Thieves Waterless Hand Sanitizer
70631-577-03
70631-577-30
70631-577-47
70631-577-60
70631-577-76
82128-001-22
82128-001-29
Young Living Essential Oils, LC. (Utah)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/07/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Toasted Vanilla Sweet & Shimmer Antibacterial Hand Sanitizer Spray
62651-015-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sparkling Rose Sweet & Shimmer Antibacterial Hand Sanitizer Spray
62651-016-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Gum Drop Hand Sanitizer
62651-024-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Pepper Mint Hand Sanitizer
62651-025-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Sugar Cookie Hand Sanitizer
62651-026-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Sweet and Shimmer Sweet Pomegranate Hand Sanitizer Spray
62651-027-01
Base4 Ventures (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Pharmacy’s Prescription Instant Hand Sanitizer with Moisturizers & Vitamin E
73597-007-08
74430-006-08
Prestige Beauty Care (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Beauty Formation Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
74430-001-08
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Living Essentials Corp. Hand Sanitizer Advanced Formula
74430-002-08
74430-008-08
74430-008-33
74730-002-08
78628-008-08
78628-008-33
Pacific Bridge Products, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
TCM Advanced Hand Sanitizer with Aloe
74430-003-02
74430-003-08
77952-003-02
77952-003-08
Tradecom Int. Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Rinse-Free Hand Sanitizer Soothing Gel 70% Alcohol Antiseptic
74430-004-16
74430-004-33
78304-004-16
78304-004-33
Blakemore Sales Corp (Missouri)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Bloom Health Antibacterial Hand Sanitizer
74430-005-02
74430-005-10
74430-005-33
77707-005-02
77707-005-10
77707-005-33
Magnet Fragrance
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Nevada National Products Antibacterial Hand Sanitizer Aloe Vera
74430-007-02
74430-007-10
74430-007-33
78462-007-02
78462-007-10
78462-007-33
Nevada Group, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-01
Tash Market Place
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-02
90061-011-01
90061-011-02
90061-011-03
90061-011-04
Watson
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer with Aloe
74430-010-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-01
Tash Market Place
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-02
90061-010-01
90061-010-02
90061-010-03
90061-010-04
Watson
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Watson Hand Sanitizer
74430-011-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Beauty Formation Instant Hand Sanitizer
74430-013-01
74430-013-02
74430-013-03
Beauty Formation
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Element Control Rinse-Free Hand Sanitizer Soothing Gel
74430-014-01
74430-014-02
79995-002-01
79995-002-02
Strategic Orient Sourcing Limited (Hong Kong)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
Yuyao Huanyan Daily Chemical Products Co., Ltd.
(China)
Living Essentials Corp Hand Sanitizer
74430-015-59
Living Essentials Corp. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/25/2023.
06/21/2023
EASTLAB Inc.
(South Korea)
Aube Hand Sanitizer with Rich Moisture
76656-100-01
K Boom Beauty, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Plant Grow Disposable Hand Sanitizer
52965-001-01
52965-002-01
52965-003-01
52965-004-01
52965-005-01
52965-006-01
52965-007-01
52965-008-01
52965-009-01
Not listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Germ Shark Antibacterial Hand Sanitizer
75158-500-06
Germ Shark LLC
(Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
CJG Instant Hand Sanitizer
77372-004-00
CJ Global Inc.
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Hand Sanitizer Gel
52965-010-01
Love 2 Design LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangzhou Da’ao Cosmetics Co., Ltd.
(China)
Hand Sanitizer
75758-001-01
75758-001-02
75758-001-03
75758-001-04
75758-001-05
75758-001-06
75758-001-07
75758-001-08
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
VizoCare Soothing Gel Hand Sanitizer
79805-001-01
79805-001-02
79805-001-03
79805-001-04
79805-001-05
79805-001-06
79805-001-07
79805-001-08
79805-001-09
79805-001-10
79805-001-11
79805-001-12
Vizocom ICT LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-01
Aldi (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
VizoCare Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-02
Vizocom ICT LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
GoldEssence Wellness Multi-purpose Antibacterial Wet Wipes (Benzalkonium Chloride 0.3%)
79805-002-03
Goldessence Limited (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Skylite Antibacterial Wet Wipes (Benzalkonium Chloride 0.13%)
79805-011-01
Aldi (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Juxin (Jiangsu) New Material Packing Co., Ltd.
(China)
Omega Clean Sanitizing Wipes
79805-010-01
JAS Supply, Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Kolts Fine Spirits
(Wyoming)
Hand Sanitizer KOLTISKA K DISTILLERY Alcohol 80% Topical Solution
74244-0001-1
74244-0375-1
Koltiska Distillery
(Wyoming)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
BeSafe Hand Sanitizer
77693-001-01
77693-001-02
77693-001-03
77693-001-04
77693-001-05
77693-001-06
77693-001-07
77693-001-08
BeSafe Industries, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
1Source Advanced Hand Sanitizer Refreshing Gel
77871-001-01
77871-001-02
77871-001-03
77871-001-04
77871-001-05
77871-001-06
77871-001-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
1Source Advanced Hand Sanitizer Liquid Foam
77871-002-01
77871-002-02
77871-002-03
77871-002-04
77871-002-05
77871-002-06
77871-002-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
5Seconds Advanced Hand Sanitizer Liquid Foam
77871-005-01
77871-005-02
77871-005-03
77871-005-04
77871-005-05
77871-005-06
77871-005-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
5Seconds Advanced Hand Sanitizer Refreshing Gel
77871-004-01
77871-004-02
77871-004-03
77871-004-04
77871-004-05
77871-004-06
77871-004-07
AVS Energy, Inc. (Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
U Instant Hand Sanitizer Classic
75112-006-01
75112-006-02
75112-006-03
75112-006-04
75112-006-05
75112-006-06
75112-006-07
75112-006-08
75112-006-09
Universal Distribution Center (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
U Instant Hand Sanitizer Aloe Vera
52000-115-03
75112-007-01
75112-007-02
75112-007-03
75112-007-04
75112-007-05
75112-007-06
75112-007-07
75112-007-08
75112-007-09
Universal Distribution Center (New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
SPIRITZ IT 2 in 1 Pen with Hand Sanitizer
75112-008-01
DMM (Illinois)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Rilakkuma Aloe Vera Scented Hand Sanitizer
75112-009-01
Aliquantum International, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Yixin Sunlin Instant Hand Sanitizer
75112-001-01
75112-001-02
75112-001-03
75112-001-04
75112-001-05
75112-001-06
75112-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Yixin Sunlin Instant Hand Sanitizer
75112-005-01
75112-005-02
75112-005-03
75112-005-04
75112-005-05
75112-005-06
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
SUDESAN Hand Sanitizer Original
75112-002-01
75112-002-02
75112-002-03
75112-002-04
75112-002-05
75112-002-06
75112-002-07
75112-002-08
XM Wholesale (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Health Smart Instant Hand Sanitizer
75112-003-01
75112-003-02
75112-003-03
75112-003-04
75112-003-05
75112-003-06
75112-003-07
75112-003-08
HomeSmart Products (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
Zhejiang Shenying Technology Co., Ltd.
(China)
Healing Solutions Premium Hand Sanitizer
75112-004-01
75112-004-02
75112-004-03
75112-004-04
75112-004-05
75112-004-06
75112-004-07
75112-004-08
75112-004-09
75112-004-10
Healing Solutions, LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/19/2023.
06/07/2023
EASTLAB Inc.
(South Korea)
D6 Plants Hand Sweeper (70% Alcohol)
76656-101-01
K Boom Beauty, Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
06/07/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant Gel Advanced Formula (75% alcohol)
76714-001-01
76714-001-03
76714-001-05
76714-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant Gel Advanced Formula (75% alcohol)
76714-001-01
76714-001-03
76714-001-05
76714-001-07
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Korusa 75% Alcohol Hand Sanitizer Gel
76714-001-02
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
CB Advanced Hand Sanitizer
76714-001-04
CB Distributors, Inc. (Wisconsin)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Dew’s Plus Disinfectant Gel Hand Sanitizer
76714-001-06
Magic Trade INC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh Kids Hand Sanitizer
76714-001-07
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
Disinfectant (75% alcohol)
76714-002-01
76714-002-02
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh 75% Alcohol Spray Disinfectant & Antimicrobial
76714-002-03
76714-002-04
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guangdong Yawei Bioscience Co Ltd.
(China)
AuraFresh 75% Alcohol Ethyl Rubbing Alcohol
76714-002-05
TopGrade Products Inc (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
Alcohol-Based Disinfectant Hand Sanitizer Gel (75% alcohol)
74757-001-01
74757-001-02
74757-001-03
74757-002-01
74757-002-02
74757-002-03
74757-002-04
74757-002-05
74757-002-06
74757-002-07
74757-002-08
74757-002-09
74757-002-10
74757-002-11
74757-002-12
74757-002-13
ATZ Med Supply (Maryland)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel
79606-001-01
79606-001-02
79606-001-03
79606-001-04
79606-001-05
79606-001-06
79606-001-07
79606-001-08
79606-001-09
79606-001-10
79606-001-11
LiveLife Corp. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Guizhou Xinzihong Pharmaceutic Adjuvant Co., Ltd.
(China)
LiveLife Corp. 75% Alcohol-Based Disinfectant Hand Sanitizer Gel
79606-002-01
79606-002-02
79606-002-03
79606-002-04
79606-002-05
79606-002-06
79606-002-07
79606-002-08
79606-002-09
79606-002-10
79606-002-11
LiveLife Corp. (Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Lifeguard Multi Purpose Antiseptic Alcohol Wipes
77879-003-01
78781-001-01
78781-006-01
Not Listed
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Pro Clean Hand Sanitizer
78781-311-10
78781-311-75
Bigbattery Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Shandong Oushile Biotechnology Co., Ltd.
(China)
Blue Unity 75% Alcohol Wet Wipes
78781-080-50
78781-080-75
78781-408-01
78781-408-04
78781-531-10
78781-531-40
RIXI Group USA Inc (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 06/28/2023.
05/31/2023
Yiwu Mango Cosmetics, Ltd.
(China)
Instant Hand Sanitizer (Alcohol 75%)
76824-001-01
76824-001-02
76824-001-03
76824-001-04
76824-001-05
76824-001-06
76824-001-07
76824-001-08
76824-001-09
76824-001-10
76824-001-11
76824-001-12
76824-001-13
Yiwu Mango Cosmetics, Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/12/2023.
05/24/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 3790mL
80806-520-02
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was subpotent. FDA has no evidence this product is in the U.S. market; added to
import alert
to help stop their products from entering the U.S. on 05/9/2023; FDA issued a
warning letter
on 08/07/2023.
05/17/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Beyond Simple Cleaners Instant Hand Sanitizer with Glycerin (Benzalkonium Chloride 0.13%) 60mL
80806-520-03
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to
import alert
to help stop their products from entering the U.S. on 05/9/2023; FDA issued a
warning letter
on 08/07/2023.
05/17/2023
Laavo Clean, S.A. de C.V.
(Mexico)
Kids Instant Hand Sanitizer (Benzalkonium Chloride 0.13%)
80806-510-01
80806-510-02
80806-510-03
80806-510-04
Laavo Clean, S.A. de C.V.
(Mexico)
FDA tested product; benzalkonium chloride level was superpotent. FDA has no evidence this product is in the U.S. market; added to
import alert
to help stop their products from entering the U.S. on 05/9/2023; FDA issued a
warning letter
on 08/07/2023.
05/17/2023
Haining Twowell Daily Commodity Co., Ltd.
(China)
Activa Hand Sanitizer Wipes
80552-001-01
80552-001-02
Blue Ribbon Supply Company
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 05/22/2023.
05/03/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Mayseen Instant Hand Sanitizer
78565-016-01
Skyelee Inc
(Georgia)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Vivitar Advanced Hand Sanitizer
Unspecified
Sakar International
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd
(China)
Healing Solutions Premium Hand Sanitizer
Unspecified
Healing Solutions LLC
(Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023
04/26/2023
Natuurs Direct, LLC
(Nevada)
Natuurs Advance Hand Sanitizer Alcohol Antiseptic 80%
75393-4800-5
Natuurs Direct, LLC
(Nevada)
Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of contamination.
04/19/2023
Natuurs Direct, LLC
(Nevada)
Natuurs Pure Liquid Sanitizer Hand & Surface Alcohol Antiseptic 80%
Not listed
Natuurs Direct, LLC
(Nevada)
FDA tested product; contains acetaldehyde and acetal contaminants; Company did not adequately respond to FDA requests for records and other information related drug manufacturing, product quality and scope of the contamination.
04/19/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
74663-001-04
74663-001-12
74663-001-55
MCS Midwest Cleaning Solutions (South Dakota)
FDA tested product; contains unacceptable levels of methanol; FDA recommended the company recall on 3/22/2023; product voluntarily
recalled
on 3/27/2023.
04/12/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution
74663-002-04
74663-002-55
74663-002-01
MCS Midwest Cleaning Solutions (South Dakota)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily
recalled
on 3/27/2023.
04/12/2023
Jarman’s Midwest Cleaning Systems, Inc. (South Dakota)
SOFT HANDS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution
77518-200-01
Clean Pro Supply, LLC (New York)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 3/22/2023; product voluntarily
recalled
on 3/27/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Macy’s Antibacterial Hand Sanitizer Gel (75% ethyl alcohol)
Unspecified
MiWorld Accessories, LLC. (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Isaac Mizrahi New York Hand Sanitizer
Unspecified
MWA, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
C Wonder Hand Sanitizing Spray
Unspecified
MWA, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
L+W Bio Hygienic Hand Sanitizer
78713-002-08
Luxe + Willow / MWA (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
C Wonder Sanitizing Gel
Unspecified
MiWorld Accessories LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Sanitize Keep Hands Clean Luxe + Willow Hand Sanitizer
Unspecified
Luxe + Willow / MWA (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Foshan Meixin Biotechnology Co., Ltd.; formerly, Meixin Beauty & Health Care Products Co., Ltd (China)
Lifeguard Hand Sanitizer
Unspecified
Lifeguard (Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/24/2023.
04/12/2023
Labisco Corporation
(South Korea)
Dr. Days V-CIDER Hand Clean Gel
75535-0003-1
Labisco Corporation
(South Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/14/2023.
04/05/2023
Labisco Corporation
(South Korea)
Dr. Day Hand Clean Gel
75535-0001-1
75535-0002-1
Labisco Corporation
(South Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/14/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
CB Advanced Hand Sanitizer
74935-005-00
74935-014-00
76813-005-00
76813-014-00
73529-353-01
CB Distributors Inc. (Wisconsin)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Steel Hand Sanitizer Disinfectant Spray
79931-001-01
Steel Supplements Inc. (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Pro-Tex Instant Hand Sanitizer
52728-020-01
GoodBuys USA Inc (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
CB Advanced Hand Sanitizer
74935-005-00
74935-014-00
76813-005-00
76813-014-00
73529-353-01
CB Distributors Inc. (Wisconsin)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Anjieshu Instant Hand Sanitizer
52728-001-01
52728-002-01
52728-003-01
52728-004-01
52728-005-01
52728-006-01
52728-007-01
52728-008-01
52728-010-01
52728-011-01
52728-012-01
52728-013-01
52728-014-01
52728-015-01
52728-017-01
52728-018-01
52728-019-01
79485-100-10
79485-100-20
79485-100-30
TAMSC Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Clever Choice Instant Hand Sanitizer Gel
62379-006-26
Simple Diagnostics, Inc. (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Tech 361 Hand Sanitizer with Aloe Vera Extract
74871-050-00
74871-050-01
74871-060-00
74871-060-01
74871-100-00
74871-100-01
iTech 361 LLC
(New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
HYTN Hand Sanitizer with Aloe Vera Extract
74871-051-00
74871-051-01
74871-061-00
74871-061-01
74871-120-00
74871-120-01
74871-237-00
74871-237-01
74871-500-00
74871-500-01
74871-900-00
74871-900-01
iTech 361 LLC
(New Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Hand Sanitizer 70% Ethyl Alcohol Aloe & Vitamin E
77725-001-08
77725-002-01
L.E.D Cosmetics Inc. (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Quality Choice Instant Hand Sanitizer
77725-003-02
77725-003-08
77725-003-17
77725-003-33
77725-004-08
C.D.M.A. Inc. (Michigan)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
First Step Advanced Hand Sanitizer
79195-001-01
79195-005-01
79195-006-01
First Step Safety Products (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Zhejiang Enchant Cosmetic Co., Ltd.
(China)
Healing Solutions Premium Hand Sanitizer
52728-016-01
77813-001-04
Healing Solutions LLC (Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/20/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
Handy Hand Sanitizer Pocket Spray
68210-4079-1
68210-4079-2
68210-4079-3
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
Handy Hand Sanitizer Solution with Vitamin E and Moisturizers
68210-4082-5
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
DR. Sanitizer Hand Sanitizer Gel with Vitamin E and Moisturizers
68210-4081-1
68210-4081-2
68210-4081-5
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
Handy Hand Sanitizer Spray with Vitamin E and Moisturizers
68210-4077-1
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
Handy Hand Sanitizer Gel with Vitamin E and Moisturizers
68210-4075-1
68210-4075-2
68210-4075-3
68210-4075-4
68210-4075-5
68210-4075-6
68210-4075-7
68210-4075-8
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
Afnan Perfumes, LLC
(United Arab Emirates)
Handy Sanitizer Spray
68210-4118-3
68210-4118-5
68210-4118-6
Spirit Pharmaceuticals, LLC (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/12/2023.
04/05/2023
BL Cosmetic Co., Ltd
(South Korea)
Mega Clean Hand Sanitizer Liquid
77799-002-01
MEGACITY Group, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/13/2023.
04/05/2023
BL Cosmetic Co., Ltd
(South Korea)
Mega Clean Hand Sanitizer
77799-001-01
77799-057-01
77799-170-01
77799-370-01
77799-570-01
MEGACITY Group, LLC (Florida)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/13/2023.
04/05/2023
BL Cosmetic Co., Ltd
(South Korea)
CEL’RAUM Forest Perfect Hand Cleaner Nonstick gel-type Hand Sanitizer
75368-010-01
75368-010-02
75368-020-01
75368-020-02
75368-030-01
75368-030-01
U&D2 Co., Ltd. (South Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/13/2023.
04/05/2023
BL Cosmetic Co., Ltd
(South Korea)
Perfect Hand Cleanser
76645-0001-1
K INTERNATIONAL Co., Ltd.
(South Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/13/2023.
04/05/2023
Ella Cosmetic Co., Ltd.
(South Korea)
Jasna Pearl Hand Gel Sanitizer
74003-010-01
74003-020-01
74003-030-01
Ella Cosmetic Co., Ltd. (South Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/10/2023.
04/05/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
JM & HFB Disinfection Instant Hand Sanitizer, 75% alcohol
55028-001-01
55028-002-01
55028-003-01
55028-004-01
55028-005-01
55028-006-01
55028-007-01
55028-008-01
55028-009-01
55028-010-01
Zhongshan Dermey Commodity Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
360+ Bio-Lab Advanced Hand Fragrance Free Antimicrobial Gel, 75% alcohol
55028-011-01
Asia Bay, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
360+ Bio-Lab Advanced Hand Sanitizer Spray, 70% alcohol
55028-012-01
55028-013-01
Asia Bay, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ShieldOurs Hand Sanitizer Refreshing Gel, 75% alcohol
55028-015-01
55028-015-02
Zhongshan Dermey Commodity Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ProtectorPlus Alcohol Hand Wipes, 75% alcohol
78378-666-01
78378-666-02
78378-666-05
78378-666-06
78378-666-07
78378-666-08
Cancreativ Packing Corp
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Zhongshan Dermey Commodity Co., Ltd.
(China)
ProtectorPlus Hand Sanitizer, 75% alcohol
78378-888-01
78378-888-02
78378-888-03
78378-888-04
78378-888-05
78378-888-06
78378-888-07
78378-888-08
Cancreativ Packing Corp
(Canada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 03/27/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Hand Sanitizer
75612-030-01
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Instant Hand Sanitizer
75612-100-01
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Beesoul Instant Hand Sanitizer
75612-101-01
75612-101-02
75612-101-03
75612-101-04
75612-101-05
75612-101-06
75612-101-10
75612-101-13
75612-101-15
75612-101-25
75612-101-37 75612-101-50
Yiwu Dieyuan Cosmetics Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/10/2023.
03/22/2023
St. Augustine Distillery LLC
(Florida)
St. Augustine Distillery Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
74324-001-01
74324-001-02
St. Augustine Distillery LLC (Florida)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
03/22/23
Raff Beverage LLC
(California)
Take A Bite Out Of Germs Hand Sanitizer
74610-008-01
74610-008-08
74610-008-16
74610-008-75
Raff Distillerie
(California)
FDA tested product; contains acetaldehyde and acetal contaminants. Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
03/22/2023
Guangzhou Cikang Biotechnology Co., Ltd. (China)
Dr. J’s Natural Advanced Formula Hand Sanitizer
74416-171-02
74416-171-03
74416-171-04
74416-171-08
74416-171-10
74416-171-16
74416-171-35
74416-172-51
73750-369-01
73750-369-02
73750-369-03
73750-369-04
73750-369-05
73750-369-06
73750-369-07
QYK Brands, LLC (California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Siruini Hand Sanitizer
74458-101-01
74458-101-02
74458-101-03
74458-101-04
74458-101-05
74458-101-06
74458-101-07
74458-101-08
74458-101-09
74458-101-10
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/05/2023.
03/22/2023
Guangzhou Yilong Cosmetics Co., Ltd.
(China)
Village Pharma Sanizen Gel Hand Sanitizer (75% alcohol)
74458-201-01
71574-711-10
Village Pharma, LLC
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/05/2023.
03/22/2023
Guangzhou Meizi Biotechnology Co., Ltd
(China)
Jean Pierre Cosmetics Antibacterial Hand Gel
79867-002-01
79867-002-02
79867-002-03
70483-018-01
70483-018-02
70483-018-03
Jean Pierre Inc.
(New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/22/2023
Guangzhou Meizi Biotechnology Co., Ltd
(China)
Expressions Hand Sanitizer
79867-001-01
Almar Sales Co.
(New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/22/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
Smart Care Advanced Hand Sanitizer
70108-070-01
74416-005-01
Ashtel Studios Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
Smart Care Hand Sanitizer Aloe Vera & Vitamin E
70108-038-01
70108-039-01
70108-040-01
70108-041-01
74416-001-01
74416-002-01
74416-003-01
74416-004-01
Ashtel Studios Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Guangzhou Cikang Biotechnology Co., Ltd.
(China)
HiGuys USA Alcohol Disinfectant
74416-170-01
74416-170-02
74416-170-03
74416-170-04
74416-170-05
74416-170-06
74416-170-07
74416-170-08
74416-170-09
74416-170-10
Lancougroup
(China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 04/03/2023
03/15/2023
Nanomaterials Discovery Corporation
(Wyoming)
Snowy Range Blue alcohol antiseptic 80% topical solution
75288-100-01
75288-100-02
75288-100-04
75288-100-06
Reliable Products, LLC
(Wyoming)
FDA tested product; contains unacceptable levels of methanol, acetaldehyde and acetal; FDA recommended the company recall on 2/9/2023; product voluntarily recalled on 2/14/2023.
03/08/2023
Innovaciones Tecnologicas Concar, SA de CV
(Mexico)
SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%)
79279-420-01
79279-420-02
79279-420-03
79279-420-04
79279-420-05
79279-421-06
79279-421-07
79279-421-08
79279-421-09
79279-421-10
79279-520-06
79279-520-07
79279-520-08
79279-520-09
79279-521-01
79279-521-02
79279-521-03
79279-521-04
79279-521-05
79279-610-01
79279-610-02
79279-610-03
79279-610-04
79279-610-05
79279-620-01
79279-620-02
79279-620-03
79279-620-04
79279-620-05
Innovaciones Tecnologicas Concar, SA de CV
(Mexico)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality.
02/22/2023
Coppercraft Distillery, LLC
(Michigan)
Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%
75293-001-02
75293-001-04
75293-001-03
75293-001-01
Coppercraft Distillery, LLC
(Michigan)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
02/22/2023
Ublendit, Inc.
(California)
Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution
74515-111
Ublendit, Inc.
(California)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination.
02/15/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Hand Sanitizer Gel
74046-001-01
74046-001-02
74046-001-03
74046-001-04
74046-001-05
74046-001-06
74046-001-07
74046-001-08
74046-001-09
74046-001-10
74046-001-11
74046-001-12
74046-001-13
74046-001-14
74046-001-15
74046-001-16
74046-001-17
74046-001-18
74046-001-19
74046-001-20
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 01/05/2023
02/01/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Hand Sanitizer Spray
74046-004-01
74046-004-02
74046-004-03
74046-004-04
74046-004-05
74046-004-07
74046-004-08
74046-004-09
74046-004-10
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 01/05/2023
02/01/2023
Dongguan Mingyi Medical Products, Co., Ltd. (China)
Benzalkonium Chloride Instant Hand Sanitizer
74046-006-01
74046-006-02
74046-006-03
74046-006-04
74046-006-05
74046-006-06
74046-006-07
74046-006-08
74046-006-09
74046-006-10
Dongguan Mingyi Medical Products, Co., Ltd.
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 01/05/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic  Hand Rub, Non-Sterile Solution,
75037-0001-1
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a
warning letter
on 05/01/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile,  1 Quart, 32 FL OZ (0.95 L)
Not listed
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a
warning letter
on 05/01/2023.
02/01/2023
Drivergent, Inc.,
(Michigan)
Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution,  Gel, 8 FL OZ (250 ml)
Not listed
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a
warning letter
on 05/01/2023.
02/01/2023
Drivergent, Inc.
(Michigan)
Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution
75037-0002-1
Drivergent, Inc.
FDA tested product; contains unacceptable levels of acetaldehyde and acetal;  Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023; FDA issued a
warning letter
on 05/01/2023.
02/01/2023
Sun Wave Wellness, LLC
(Florida)
Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent
75023-0001
75023-0002
75023-0003
75023-0004
75023-0005
Sun Wave Wellness, LLC
FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination.
01/18/2023
Frenda Corporation
(Puerto Rico)
Global Care Antibacterial Hand Sanitizer
74115-001-00
74115-000-00
72146-000-01
72146-020-01
Target Price Inc.
(Puerto Rico)
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a
warning letter
on 02/15/2023.
12/21/2022
Frenda Corporation
(Puerto Rico)
Easy Klean Hand Sanitizer
74115-002-00
Frenda Corporation
(Puerto Rico)
Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. FDA recommended the company recall all drug products on 12/12/2022; FDA issued a
warning letter
on 02/15/2023.
12/21/2022
Mohawk Laboratories Division
(Texas)
Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution
55533-523-01
55533-524-01
55533-524-02
55533-524-03
55533-524-04
MULTI-MIST Products
(Texas)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022.
12/14/2022
Ultra Chem Labs, Corp.
(California)
Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer
79208-001-50
79208-001-32
79208-001-01
Ultra Chem Labs
Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; after FDA recall recommendation, the firm announced a voluntary recall on 10/18/2022; FDA issued a
warning letter
on 12/20/2022.
11/16/2022
Adam's Polishes LLC
(Colorado)
Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. Topical Solution
74943-125-04
74943-125-08
74943-125-16
74943-125-28
B&B Blending, LLC,
Northglenn, CO
FDA tested product; contains methanol; product voluntarily
recalled
on 11/5/2022.
11/16/2022
Urban Electric Power
(New York)
Ohm Sanitizer Spray 80% alcohol
774135-564-01
Urban Electric Power
(New York)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination.
11/09/2022
Urban Electric Power
(New York)
Ohm Hand Sanitizer 70% Alcohol
74135-001-01
Urban Electric Power
(New York)
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination.
11/09/2022
Flavor Vapors, LLC, dba: Mob Liquid Labs
(Nevada)
Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution
75116-075-60
Flavor Vapors, LLC
FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022
10/19/2022
Salon Technologies International
(Florida)
Salon Technologies International Sanitizing Hand Spray 80%
76804-001-01
Salon Technologies International
FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firm’s testing identified benzene in another product. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a
warning letter
on 12/21/2022.
10/06/2022
Salon Technologies International
(Florida)
Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%
76804-009-01
80097-007-01
Antica Farmacista
Company tested product; contains benzene. FDA recommended the company recall on 9/14/2022; product voluntarily
recalled
lot 1166A on 9/17/2022; FDA issued a
warning letter
on 12/21/2022.
10/06/2022
Unibeleza Industria E Comercio De
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant
77457-014-01
77457-015-01
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Venice Cosmetic (Korea)
Reborncare Hand Sanitizer (100mL, 250mL, 500mL)
79486-100-01
79486-101-01
79486-102-01
Reborncare Co. Ltd
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic (Korea)
Natural Bloom Hand Sanitizer Gel
78017-100-01
Natural Bloom
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic (Korea)
MAY MEDIC Clean Sanitizer gel
74488-500-01
74488-500-02
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
PEI FAN Instant Hand Sanitizer with Aloe
75183-006-01
75183-006-02
75183-006-03
75183-006-04
75183-006-05
75183-006-06
75183-006-07
Zorin Pharmaceutical Technology Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
Safe Hand Sanitizer with Aloe
75183-008-01
K&B Global Corp
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Zorin Pharmaceutical Technology Co. Ltd. (China)
Zorari Waterless Disinfection Gel
75183-010-01
75183-010-02
75183-010-03
Zorin Pharmaceutical Technology Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/12/2022
09/14/2022
Unibeleza Industria E Comercio De
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Sanitizing Hand Wipes
77457-011-01
77457-011-02
77457-011-03
77457-012-01
77457-012-02
77457-013-01
77457-013-02
77457-013-03
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Unibeleza Industria E Comercio De
Cosmeticos Ltda, (Brazil)
Biotipo Pharma Medical Biogel
77457-000-01
77457-000-02
77457-000-03
77457-000-04
77457-000-05
77457-000-06
77457-000-07
77457-000-08
77457-001-01
77457-001-02
77457-001-03
77457-001-04
77457-001-05
77457-002-01
77457-002-02
77457-002-03
77457-006-01
Biotipo Brazil
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/18/2022
09/14/2022
Venice Cosmetic
(Korea)
LK Hand Clean Gel
(Ethanol)
74488-012-01
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic
(Korea)
LK New Antiseptic
(Ethanol)
74488-003-01
74488-011-01
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Venice Cosmetic
(Korea)
LK Clean Gel
(Ethanol)
74488-001-01
74488-002-01
74488-004-01
74488-005-01
74488-006-01
74488-007-01
74488-008-01
74488-009-01
Venice Cosmetic
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 09/09/2022.
08/17/2022
Skin Farm
(Korea)
PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil
73793-0006-1
73793-0007-1
73793-0008-1
Sports Med Care, Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2022.
08/17/2022
Skin Farm
(Korea)
Germ War Hand Sanitizer
73793-0001-1
73793-0002-1
73793-0003-1
73793-0004-1
73793-0005-1
73793-0009-1
73793-0010-1
73793-0011-1
73793-0012-1
DJO LLC.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2022.
08/17/2022
Clean Cosmetics, LLC
(California)
TrustRx Medical Grade Hand Sanitizer
80843-001-01
80843-001-02
80843-001-03
Clean Cosmetics, LLC
(California)
Product contains methanol based on information provided by the manufacturer. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a
warning letter
on 01/30/2023.
08/03/2022
Guangdong Theaoson Technology  Co. Ltd. (China)
75% Alcohol Hand Sanitizer Gel
78792-012-04
78792-012-06
78792-012-07
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology  Co. Ltd. (China)
Antibacterial Hand Sanitizer with Moisturize
Aloe
78792-012-05
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology Co. Ltd. (China)
75% Alcohol Sanitizer
78792-010-01
78792-012-01
78792-012-02
78792-012-03
Guangdong Theaoson Technology Co., Ltd. (China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Hand Disinfectant Gel
75226-004-01
75226-004-02
75226-004-03
75226-004-04
75226-004-05
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong Theaoson Technology  Co. Ltd. (China)
75% Alcohol Sanitizer Spray
78792-011-01
78792-011-02
78792-011-03
78792-011-04
Guangdong Theaoson Technology Co., Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
JPR Medical Disinfecting Wipes (75% alcohol)
54325-004-01
Guangdong JunBao Industry Co.,  Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
Alcohol Cleaning Wet Wipes
54325-001-01
54325-002-01
Guangdong JunBao Industry Co.,  Ltd.
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
Be Cleaner Be Healthier 75% Alcohol Wipes
54325-003-01
BM Time Co.
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Disinfectant Spray
75226-001-01
75226-001-02
75226-001-03
75226-001-04
Guangzhou Wantuo Biotechnology Co. LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Disinfectant Wet Wipes
75226-002-01
75226-002-02
75226-002-03
75226-002-04
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Guangdong JunBao Industry Co. Ltd. (China)
One Drop Care Alcohol Solution
75226-003-01
75226-003-02
75226-003-03
Guangzhou Wantuo Biotechnology Co LTD
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 08/16/2022.
07/20/2022
Hand Sanitizer LLC
(Louisiana)
Hand Sanitizer
Say Goodbye to Germs
Alcohol Antiseptic 80% Topical Solution
Not Listed
Hand Cleansing Gel
(Louisiana)
FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022.
4/27/2022
Hand Sanitizer LLC
(Louisiana)
70% Alcohol Cleansing Gel Say Goodbye to Germs
76701-700-02
76701-700-08
76701-700-17
76701-700-32
Hand Cleansing Gel  (Louisiana)
Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants;  FDA recommended a recall on 3/29/2022.
4/27/2022
Bluebonnet Petrochemical Solutions (USA)
HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution
75339-751-01
75339-751-02
75339-751-03
75339-751-04
75339-751-05
75339-751-06
EcoWerks
FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022
04/06/2022
Aroma Release Technologies, Inc.
Klean Touch Hand Sanitizer
75076-123-55
75076-234-55
Valisa MFG LLC
Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. product voluntarily recalled on 11/30/2021
11/24/21
Aroma Release Technologies, Inc.
kleantouch HAND SANITIZER, 8.0 FL OZ
Not listed
Valisa MFG LLC
Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021
12/15/2021
Aromas Para El Alma SA (Costa Rica)
Erewhon Hand Sanitizer with Eucalyptus Oil
80751-100-01
80751-200-02
Erewhon Market LLC (California)
Product subpotent; product manufactured at a facility that did not respond adequately to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 2/29/2024
03/13/2024
Aromas Para El Alma SA (Costa Rica)
Erewhon Antibacterial Spray with Lemon Oil Rosemary Oil Eucalyptus Oil Clove Bud Oil Cinnamon Oil
80751-300-02
80751-300-07
Erewhon Market LLC (California)
Product subpotent; product manufactured at a facility that did not respond adequately to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 02/29/2024.
03/13/2024
Dongguan Chunzhen Biological Technology Co., Ltd (China)
Acvioo Advanced Hand Sanitizer
71847-1107-3
Anewish, Inc
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/26/2020.
11/24/21
HealthMEDS, Inc. Oregon)
ProClean-Pure Atomizer Mist
75411-001-02
HealthMEDS, Inc
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued
warning letter
on 9/29/2021.
11/24/21
HealthMEDS, Inc. (Oregon)
ProClean-Pure Atomizer Mist
75411-001-02
HealthMEDS, Inc
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued
warning letter
on 9/29/2021.
11/24/21
Ardil Comercial SRL
Alcohol Isopropilico Hand Sanitizer Limar
77854-030-04
Ardil Comercial SRL
Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021; product
recalled
on 7/1/2021; FDA issued a
warning letter
on 09/22/2021
06/16/2021
4E Global SAPI de CV (Mexico)
Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe
60599-018-00
60599-018-02
60599-018-04
4E Brands North America LLC
FDA tested product; contains  methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E
60599-015-00
4E Brands North America LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E
60599-015-01
60599-015-02
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/11/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
KLAR AND DANVER Instant Hand Sanitizer
33992-8010-1
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
MODESA Instant Hand Sanitizer Moisturizers and Vitamin E
60599-007-33
Midwood Brands LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Hand Sanitizer
60599-012-04
60599-012-08
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Hand Sanitizer
60599-012-00
60599-012-01
60599-012-02
60599-012-03
60599-012-05
60599-012-06
60599-012-07
60599-012-10
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Hand Sanitizer Aloe
60599-013-00
60599-013-01
60599-014-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Instant Hand Sanitizer Lavender
60599-016-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear Advanced Hand Sanitizer
60599-018-02
60599-018-04
60599-018-06
60599-018-07
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear Advanced Hand Sanitizer
60599-017-00
60599-018-01
60599-018-02
60599-018-04
60599-018-06
60599-018-07
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear LEAR Advanced Hand Sanitizer
60599-017-00
60599-018-01
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear LEAR Advanced Hand Sanitizer
60599-017-01
60599-018-03
60599-018-05
60599-018-08
60599-019-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
The Honeykeeper Hand Sanitizer
60599-020-00
60599-020-01
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Advanced Hand Sanitizer Clear
60599-024-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear Advanced Instant Hand Sanitizer
60599-025-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear Advanced Instant Hand Sanitizer Aloe
60599-026-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Clear Advanced Instant Hand Sanitizer Lavender
60599-027-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol
60599-028-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol
60599-029-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily
recalled
on 7/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol
60599-046-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol
60599-047-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Blumen Antibacterial Fresh Citrus Hand Sanitizer
60599-501-01
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Blumen Hand Sanitizer Fresh Citrus
60599-502-01
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
KLAR and DANVER Instant Hand Sanitizer
60599-801-00
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product
60599-802-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Assured Instant Hand Sanitizer (Vitamin E and Aloe)
60599-850-00
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers
07/08/2020
4E Global SAPI de CV (Mexico)
Assured Instant Hand Sanitizer (Aloe and Moisturizers)
60599-851-00
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers
07/08/2020
4E Global SAPI de CV (Mexico)
Assured Instant Hand Sanitizer Vitamin E and Aloe
60599-852-00
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers
07/08/2020
4E Global SAPI de CV (Mexico)
Assured Instant Hand Sanitizer Aloe and Moisturizers
60599-853-00
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/24/2020; FDA issued a
warning letter
on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Instant Hand Sanitizer Fragrance Free
60599-854-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
BLUMEN Instant Hand Sanitizer Aloe Vera
60599-855-00
4E Brands North America LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020
07/08/2020
4E Global SAPI de CV (Mexico)
Assured Aloe
60599-999-10
Greenbrier International Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers
07/08/2020
AAA Cosmetica (Mexico)
bio aaa Advance Hand Sanitizer
76987-402-01
74840-402-01
Payless Janitorial Corporation
FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/7/2020; product voluntarily
recalled
on 7/14/2020; FDA issued a
warning letter
on 2/3/2021
07/06/2020
AAA Cosmetica (Mexico)
bio aaa Advance Hand Sanitizer 480 mL bottles
Not listed
AJR Trading LLC
Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/7/2020; product voluntarily
recalled
on 9/3/2020; FDA issued a
warning letter
on 2/3/2021
09/04/2020
AAA Cosmetica (Mexico)
LumiSkin Advance Hand Sanitizer
76987-120-01
Soflo Urban Team LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/7/2020; FDA issued a
warning letter
on 2/3/2021
07/06/2020
AAA Cosmetica (Mexico)
LumiSkin Advance Hand Sanitizer
76987-402-02
Soflo Urban Team LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/7/2020; FDA issued a
warning letter
on 2/3/2021
07/06/2020
AAA Cosmetica (Mexico)
QualitaMed Hand Sanitizer
76987-250-01
QualitaMed Corp.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/7/2020; FDA issued a
warning letter
on 2/3/2021
07/06/2020
Albek de Mexico SA de CV (Mexico)
NEXT Hand Sanitizer
50066-605-08
Genomma Lab USA
FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
NuuxSan Instant Antibacterial Hand Sanitizer
72758-001-08
72758-002-08
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
NuuxSan Instant Hand Sanitizer
72758-003-00
72758-003-01
72758-005-01
72758-005-02
72758-005-03
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers
72758-009-23
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe
72758-010-23
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera
72758-011-23
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Albek de Mexico SA de CV (Mexico)
Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E
72758-012-23
Albek de Mexico SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/4/2020; FDA issued a
warning letter
on 3/11/2021
07/28/2020
Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)
Argent Defense Group Hand Sanitizer
77927-100-07
77927-100-11
ABN Corporation
FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; FDA issued a
warning letter
on 2/22/2021
09/01/2020
Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)
Dolphin Hands Sanitizer
77927-100-04
77927-100-08
Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; FDA issued a
warning letter
on 2/22/2021
09/01/2020
Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)
Hand Sanitizer Antiseptic Hand Gel 70-2
77927-100-05
77927-100-06
77927-100-09
77927-100-10
Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; FDA issued a
warning letter
on 2/22/2021
09/01/2020
Asiaticon SA de CV (Mexico)
V-KLEAN Hand Sanitizer Gel
Not listed
Astrum LLC
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
V-KLEAN Hand Sanitizer Gel
75192-001-01
75192-002-04
Asiaticon
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
V-KLEAN Hand Sanitizer Gel
75192-002-01
75192-002-02
Acadia Mercantil Corp.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
V-KLEAN Hand Sanitizer Gel
75192-002-03
Protex Labs
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages)
75192-003-01
75192-003-02
75192-003-03
Protex Labs
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
V-KLEAN
75192-100-01
SWCH LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
Medically Minded Hand Sanitizer Gel
75192-500-01
75192-600-01
SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada)
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Asiaticon SA de CV (Mexico)
Protz Real Protection Antibacterial Hand Sanitizer
75192-600-02
Safety-Med Products
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
on 8/25/2020; FDA issued a
warning letter
on 10/29/2020
08/06/2020
Bionateo Sp z.o.o.
(Poland)
Altaio Hand Sanitizing Gel
78571-002-02
Bionateo Sp z.o.o. (Poland)
FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product
added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021
05/26/2021
Bionateo Sp z.o.o. (Poland)
Altaio Hand Sanitizing Gel
78571-002-01
78571-002-03
78571-002-04
78471-002-05
Bionateo Sp z.o.o.
(Poland)
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product
added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021
added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021
05/26/2021
Bionateo Sp z.o.o. (Poland)
Altaio Hand Sanitizer Topical Solution
78581-001-01
78581-001-02
78581-001-03
78581-001-04
78571-001-05
78571-001-06
Bionateo Sp z.o.o. (Poland)
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product
added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021. FDA issued a warning letter on 11/4/2021
05/26/2021
Bionateo Sp z.o.o.(Poland)
Altaio Hand Sanitizing Wipes (80% Ethanol)
78581-003-01
Bionateo Sp z.o.o. (Poland)
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021; FDA issued a
warning letter
on 11/4/2021
05/26/2021
Bionateo Sp z.o.o. (Poland)
Altaio Hand Sanitizing Wipes (70% Ethanol)
78571-004-01
Bionateo Sp z.o.o. (Poland)
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021; FDA issued a
warning letter
on 11/4/2021
05/26/2021
Bionateo Sp z.o.o.(Poland)
Altaio Hand Sanitizer Spray
78571-005-01
78571-005-02
78571-005-03
Bionateo Sp z.o.o. (Poland)
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 6/7/2021; FDA issued a
warning letter
on 11/4/2021
05/26/2021
Bon Cosmetics Co., Ltd. (Korea)
Perfect Hand Sanitizer
74001-0002-1
74001-0004-1
74001-0005-1
74001-0006-1
Bon Cosmetics Co., Ltd. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/01/2022
Bon Cosmetics Co., Ltd. (Korea)
BVG Zero Hand Sanitizer
BVG Clean Hand Sanitizer
74001-0001-1
74001-0003-1
Bon Cosmetics Co., Ltd. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/01/2022
Bon Cosmetics Co., Ltd. (Korea)
Naturia Professional Green Hand Sanitizer
74001-0007-1
Bon Cosmetics Co., Ltd. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/01/2022
Bon Cosmetics Co., Ltd. (Korea)
Essentials by Urban Secrets Hand Sanitizer
75585-030-01
75585-050-01
75585-050-02
75585-050-03
75585-070-01
75585-070-02
75585-070-03
75585-070-04
Pro’s Choice Beauty Care (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/01/2022
Bon Cosmetics Co., Ltd. (Korea)
Essentials by Urban Secrets Advanced Hand Sanitizer
75585-040-01
75585-060-01
Pro’s Choice Beauty Care (New York)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/01/2022
Botanicals Internacional SA de CV (Mexico)
Alcohol Antiseptic 80% topical solution hand sanitizer
51384-001-01
51384-001-02
Pure Haven
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol
51384-002-01
Inambtec SA de CV
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
All Clear Hand Sanitizer Fragrance Free
51384-004-01
Good Fibers LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
Total Pure Alcohol Based Hand Sanitizer Gel
51384-003-01
51384-003-02
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
70% Alcohol Gel Hand Sanitizer
51384-500-10
51384-500-11
51384-500-23
51384-500-47
51384-500-94
USMed Supplies LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
ResQue 1st Instant Hand Sanitizer
73762-100-10
73762-100-11
73762-100-23
73762-100-47
73762-100-94
Quick Aid LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
70% Alcohol Gel Hand Sanitizer
78072-400-10
78072-400-11
78072-400-23
78072-400-47
78072-400-94
LTD Enterprises Distribution
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Botanicals Internacional SA de CV (Mexico)
70% Alcohol Gel Hand Sanitizer
78072-500-10
78072-500-11
78072-500-23
78072-500-47
78072-500-94
USMed Supplies LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/3/2021
08/06/2020
Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi)
Comfort & Mercy Hand Sanitizer
75179-303-03
Cathead Distillery
FDA tested product; contains acetaldehyde and acetal contaminants. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. FDA recommended the company recall on 06/01/2022.
06/01/2022
Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi)
Comfort & Mercy Hand Sanitizer
75179-313-05
75179-313-16
Cathead Distillery
Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. FDA recommended the company recall on 06/01/2022.
06/01/2022
Broncolin SA de CV (Mexico)
Herbacil Antiseptic Hand Sanitizer 70% Alcohol
62583-020-08
INBC Trading LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily
recalled
on 7/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/29/2020; FDA issued a
warning letter
on 12/21/2020
07/24/2020
Broncolin SA de CV (Mexico)
Herbacil Antiseptic Hand Sanitizer 70% Alcohol
62583-020-16
62583-020-33
62583-020-42
INBC Trading LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily
recalled
on 7/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/29/2020; FDA issued a
warning letter
on 12/21/2020
07/24/2020
Broncolin SA de CV (Mexico)
Herbacil Antiseptic Hand Sanitizer 70% Alcohol
74673-001-08
74673-001-16
74673-001-33
74673-001-42
INBC Trading LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily
recalled
on 7/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/29/2020; FDA issued a
warning letter
on 12/21/2020
07/24/2020
C&G Laboratorios SA de CV (Mexico)
Hand Sanitizer Disenfectant Gel
Not Listed
Access USA
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/9/2020
10/01/2020
Corporativo Bureli SA de CV (Mexico)
Soho Fresh Hand Sanitizer Gel Antibacterial
79081-000-03
SOHO Fresh
FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/24/2020; FDA issued a
warning letter
on 12/1/2020
09/16/2020
Corporativo Bureli SA de CV (Mexico)
SOHO Fresh Hand Sanitizer Gel Antibacterial
79081-000-01
79081-000-02
79081-000-04
78533-000-02
78533-000-08
78533-000-16
78533-000-33
SOHO Fresh and Essaar Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/24/2020; FDA issued a
warning letter
on 12/1/2020
09/16/2020
Corporativo Bureli SA de CV (Mexico)
SOHO Fresh Rubbing Alcohol
78533-001-33
SOHO Fresh
Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by
Essaar Inc.
on 1/4/2021; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/24/2020; FDA issued a
warning letter
on 12/1/2020
01/11/2021
David Cosmetic Co, Ltd.
(Korea)
CALA Advanced Hand Sanitizer with Aloe Vera Extract
58241-0009-1
CALA Products (California)
FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2022; FDA issued a
warning letter
on 05/02/2022
01/12/2022
DDI Multinacional SA de CV (Mexico)
Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced
74949-002-20
74949-002-25
74949-002-49
74949-002-60
Earths Amenities
FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/13/2020; FDA issued a
warning letter
on 06/27/2022
07/08/2020
DDI Multinacional SA de CV (Mexico)
Hand Sanitizer Agavespa Skincare
77415-000-00
Vidanos Easy Cleaning Rentals
FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/13/2020; FDA issued a
warning letter
on 06/27/2022
07/08/2020
DDI Multinacional SA de CV (Mexico)
Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare
77056-000-01
Vidanos Easy Cleaning Rentals
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/13/2020; FDA issued a
warning letter
on 06/27/2022
07/08/2020
DEPQ Internacional S de RL de CV (Mexico)
dgreen Advanced Sanitizer Alcohol Free
74155-211-04
74155-211-07
74155-211-08
74155-211-19
74155-211-20
74155-211-38
Biokaab Inc.
FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/31/2020; FDA issued a
warning letter
on 3/18/2021
08/03/2020
DEPQ Internacional S de RL de CV (Mexico)
dgreen Advanced Hand Sanitizer Antibacterial Gel
74155-201-03
74155-201-19
74155-201-20
74155-201-38
Biokaab Inc.
Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/31/2020; FDA issued a
warning letter
on 3/18/2021
08/03/2020
DEPQ Internacional S de RL de CV (Mexico)
Hand Sanitizer
74155-111-07
74155-111-08
74155-111-19
74155-111-20
74155-111-38
Biokaab Inc.
Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/31/2020; FDA issued a
warning letter
on 3/18/2021
08/03/2020
DEPQ Internacional S de RL de CV (Mexico)
Hand Sanitizer Gel
74155-101-07
74155-101-08
74155-101-19
74155-101-20
74155-101-38
Biokaab Inc.
Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/31/2020; FDA issued a
warning letter
on 3/18/2021
08/03/2020
DEPQ Internacional S de RL de CV (Mexico)
Clean Humans Hand Sanitizer
Not listed
Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/31/2020; FDA issued a
warning letter
on 3/18/2021
08/03/2020
Dibar Nutricional S De RL de CV (Mexico)
Dibar Labs Hand Sanitizer
73009-001-08
S.E.N.D. LLC
FDA tested product; contains methanol; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily
recalled
on 5/11/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Dibar Labs Hand Sanitizer
73009-001-16
73009-003-04
73009-003-32
S.E.N.D. LLC
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily
recalled
on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
ProtectoRx Hand Sanitizer Extra Strength
73009-002-01
73009-002-02
75408-002-01
75408-002-02
PR Trading LLC
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily
recalled
on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Eztizer Hand Sanitizer
73009-005-01
73009-005-02
73009-005-03
73009-005-04
73009-005-05
73009-005-06
Dibar Labs
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Advance Hand Sanitizer
73009-010-00
79284-005-00
Lifetime Health Services
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/18/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Basic Care Gel Hand Sanitizer
73009-015-01
73009-015-02
79695-015-01
79695-015-02
Nora Foods Inc.
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Genesis Today Advanced Hand Sanitizer
73009-016-01
62400-0016-1
West Town Brands
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Wellnicity Hand Sanitizer
73009-017-01
62400-0017-1
Wellnicity
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Dibar Nutricional S De RL de CV (Mexico)
Bklen Hands Sanitizer
73009-018-01
73009-018-02
73009-018-03
73009-018-04
73009-018-05
81081-000-01
81081-000-02
81081-000-03
81081-000-04
81081-000-05
Garflo Foods
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
(66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a
warning letter
on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to
import alert
(66-78) on 6/22/2021
04/29/2021
Distribuidora Lagunera del Norte SA de CV (Mexico)
Weper Clean Solutions
76527-001-03
Ekko’s Venture LLC
FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2021; FDA issued a
warning letter
on 3/23/2021
01/28/2021
Distribuidora Lagunera del Norte SA de CV (Mexico)
Weper Clean Solutions
76527-001-01
76527-001-02
76527-001-04
76527-001-05
76527-001-06
76527-001-07
Ekko’s Venture LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2021; FDA issued a
warning letter
on 3/23/2021
01/28/2021
Distribuidora Lagunera del Norte SA de CV (Mexico)
CyroLab Q&T Antibacterial Gel
78907-001-01
78907-001-02
78907-001-03
78907-001-04
78907-001-05
Distribuidora Lagunera del Norte SA de CV
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2021; FDA issued a
warning letter
on 3/23/2021
01/28/2021
Distribuidora Lagunera del Norte SA de CV (Mexico)
Kleengel Hand Sanitizer
76527-002-01
76527-002-02
76527-002-03
76527-002-04
76527-002-05
76527-002-06
76527-002-07
76527-002-02
Comdata Laguna S de RL de CV
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2021; FDA issued a
warning letter
on 3/23/2021
01/28/2021
Distribuidora Lagunera del Norte SA de CV (Mexico)
Kilvir Forte Virus Killer
76527-003-01
76527-003-02
76527-003-03
76527-003-04
76527-003-05
76527-003-06
76527-003-07
76527-003-08
Comdata Laguna S de RL de CV
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 3/10/2021; FDA issued a
warning letter
on 3/23/2021
01/28/2021
DMM Vission SA de CV (Mexico)
SYP Health Hand Sanitizer Alcohol Gel
75799-000-03
FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; FDA issued a
Warning Letter
on 06/03/2021
08/21/2020
DMM Vission SA de CV (Mexico)
Cleaner by Crystalware Hand Sanitizer Alcohol Gel
74840-402-05
CrystalWare
FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a
Warning Letter
on 06/03/2021
08/21/2020
DMM Vission SA de CV (Mexico)
Cleaner by Crystalware Hand Sanitizer Alcohol Gel
75799-000-02
75799-000-04
CrystalWare
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; product voluntarily
recalled
on 9/8/2020; FDA issued a
Warning Letter
on 06/03/2021
08/21/2020
DMM Vission SA de CV (Mexico)
SYP Health Hand Sanitizer Alcohol Gel
75799-000-01
Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a
Warning Letter
on 06/03/2021
08/21/2020
Eskbiochem SA de CV
(Mexico)
CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol
74589-009-01
ESPMEX LLC
FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
Lavar 70 Gel Hand Sanitizer
74589-006-01
Blue Ridge Southern Supply LLC
FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
All-Clean Hand Sanitizer
74589-002-01
All Clean Natural LTD
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by
ITECH 361
on 7/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
Esk Biochem Hand Sanitizer
74589-007-01
EskBiochem
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
The Good Gel Antibacterial Gel Hand Sanitizer
74589-010-10
EskBiochem SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol
74589-005-03
ESPMEX LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol
74589-003-01
ESPMEX LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Eskbiochem SA de CV
(Mexico)
Saniderm Advanced Hand Sanitizer
74589-001-01
Polarized LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by
Saniderm Products
on 6/26/2020 and
UVT Inc.
on 6/29/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 7/23/2020
07/02/2020
Estrategia Hospitalaria SA de CV (Mexico)
OZO Hand Sanitizer, Luxury Formula
Not listed
Ancorp Capital Group USA
FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/14/2020
08/06/2020
Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)
Pristine Hand Sanitizer Gel
76938-001-01
Universal Distributors LLC
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/22/2020; FDA issued a
warning letter
on 3/1/2021
11/20/2020
Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)
Pristine Hand Sanitizer Gel
76938-001-02
76938-001-03
Universal Distributors LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/22/2020; FDA issued a
warning letter
on 3/1/2021
11/20/2020
Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)
Zapien Productos Hand Sanitizer Gel
76938-100-02
Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/22/2020; FDA issued a
warning letter
on 3/1/2021
11/20/2020
Genesis Partnership Company SA (Guatemala)
Panagel Hand Sanitizer
78384-001-01
72384-001-02
78384-001-03
78384-001-04
Central-Med Distribution Inc.
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
Panagel Hand Sanitizer
74625-002-01
74625-002-04
74625-002-05
74625-003-01
74625-003-04
74625-003-05
Killz Germz LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
Panagel Hand Sanitizer
76988-001-01
76988-001-03
DJR Trading
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
SensiMedical Hand Sanitizer Gel
78718-763-01
78718-763-02
78718-763-03
78718-763-04
78718-763-05
78718-763-06
Sensimedical LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
Genesis Hand Sanitizer Gel
74484-001-01
74484-001-02
74484-001-03
74484-001-04
74484-002-01
74484-002-02
74484-002-03
74484-002-04
74484-002-05
74484-002-06
Genesis Partnership Company SA (Guatemala)
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
Medtek Supplies Hand Sanitizer
78901-001-01
Wide Evolution Systems
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/2/2020
08/28/2020
Genesis Partnership Company SA (Guatemala)
Bathletix HAND SANITIZER
74484-002-01; 74484-002-02
BH Deals & Closeout, Inc.
Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021.
09/08/2021
Grupo Asimex de Mexico SA de CV (Mexico)
Florance Morris Body Care Antispetic Hand Sanitizer
76612-170-06
76612-170-10
76612-170-11
76612-170-12
76612-170-25
76612-170-37
76612-170-50
76612-180-10
76612-180-12
76612-180-25
76612-180-37
76612-180-50
Asimex International LLC
FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/17/2020; product voluntarily
recalled
on 8/17/2020; FDA issued a
warning letter
on 11/6/2020
08/13/2020
Grupo Asimex de Mexico Sa de CV (Mexico)
Florance Morris Body Care Antispetic Hand Sanitizer
77409-170-06
77409-170-10
77409-170-11
77409-170-12
77409-170-25
77409-170-37
77409-170-50
77409-180-10
77409-180-12
77409-180-25
77409-180-37
77409-180-50
Asimex International LLC
FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/17/2020; product voluntarily
recalled
on 8/17/2020; FDA issued a
warning letter
on 11/6/2020
08/13/2020
Grupo Asimex de Mexico Sa de CV (Mexico)
Florance Morris Body Care Antispetic Hand Sanitizer
79109-170-06
79109-170-10
79109-170-11
79109-170-12
79109-170-22
79109-170-25
79109-170-37
79109-170-50
Roldan Industries
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/17/2020; product voluntarily
recalled
on 8/17/2020; FDA issued a
warning letter
on 11/6/2020
08/13/2020
Grupo Insoma S.A.P.I de CV (Mexico)
Hand sanitizer Gel Unscented 70% Alcohol
75744-0200-3
75744-0200-4
75744-0201-5
75744-0202-1
75744-0250-1
75744-0250-2
75744-0500-1
75744-1000-1
75744-1000-3
75744-1001-1
Grupo Insoma S.A.P.I de CV
FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 10/23/2020
07/02/2020
Grupo Insoma S.A.P.I de CV (Mexico)
Hand sanitizer Gel Unscented 70% Alcohol
Not listed
CIRG Waste & Recycling Solutions US LLC
FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 10/23/2020
08/06/2020
Grupo Plast Y Kosas SA de CV (Mexico)
M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer
75432-001-02
Medek LLC
FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; product voluntarily
recalled
by Medek LLC on 9/9/2020; FDA issued a
warning letter
on 1/25/2021
08/11/2020
Grupo Plast Y Kosas Sa De CV (Mexico)
Hand Sanitizer Alcohol Antiseptic topical solution 80%
77797-001-01
75432-001-01
Medek LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 1/25/2021
08/11/2020
Grupo Plast Y Kosas SA de CV (Mexico)
Jalisco Paper Inc. Restaurant Supplies Hand Sanitizer
77797-001-02
75432-001-03
Medek LLC
FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 1/25/2021
08/11/2020
Grupo Plast Y Kosas SA de CV (Mexico)
O.K. Pharmacy Hand Sanitizer
77797-001-03
75432-001-04
Medek LLC
FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 1/25/2021
08/11/2020
Grupo Yacana Mexico SAS de CV (Mexico)
Yacana Alcohol Antiseptic 70% Topical Solution
76592-002-01
76592-002-02
76592-002-03
76592-002-04
76592-002-05
76592-002-06
76592-002-07
Greensys of North America LLC
FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily
recalled
on 8/18/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/20/2020; FDA issued a
warning letter
on 1/26/2021
08/13/2020
Grupo Yacana Mexico SAS de CV (Mexico)
Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution
76592-001-01
76592-001-02
76592-001-03
76592-001-04
Greensys of North America LLC
FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily
recalled
on 8/18/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/20/2020; FDA issued a
warning letter
on 1/26/2021
08/13/2020
Grupo Yacana Mexico SAS de CV (Mexico)
Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel
76592-003-01
76592-003-02
76592-004-01
76592-004-02
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily
recalled
on 8/18/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/20/2020; FDA issued a
warning letter
on 1/26/2021
08/13/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
IMC Wash-Free Hand Sanitizer
Not listed
IMC
FDA tested product; contains methanol; product voluntarily recalled by
Shane Erickson
on 12/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the manufacturer recall on 1/25/2020. FDA issued a
warning letter
on 12/14/2021
12/15/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
Yuame Wash-Free Hand Sanitizer Gel
75132-001-01
75132-001-02
75132-001-03
75132-001-04
75132-001-05
75132-001-06
75132-001-07
75132-001-08
75132-001-09
75132-001-10
75132-001-11
75132-001-12
75132-001-13
75132-001-14
75132-001-15
75132-001-16
75132-001-17
Guangdong Kemei Pharmaceutical Technology Co. Ltd
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020.  FDA issued a
warning letter
on 12/14/2021
12/15/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
Yuame 75% Alcohol Disinfectant
75132-002-01
75132-002-02
75132-002-03
75132-002-04
75132-002-05
75132-002-06
75132-002-07
75132-002-08
75132-002-09
75132-002-10
Guangdong Kemei Pharmaceutical Technology Co. Ltd
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a
warning letter
on 12/14/2021
12/15/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
Yuame Wash-Free Hand Sanitizer Gel
75132-011-01
75132-011-02
75132-011-03
Guangdong Kemei Pharmaceutical Technology Co. Ltd
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a warning letter on 12/14/2021
12/15/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
KLEAN KARE Hand Sanitizer Industrial and Hospital Grade
77205-001-01
77205-001-02
AMG LLC
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a
warning letter
on 12/14/2021
12/15/2020
Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)
Essentials, M.D. Hand Sanitizer Industrial and Hospital Grade
77205-002-01
77205-002-02
AMG LLC
Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/2020. FDA issued a
warning letter
on 12/14/2021
12/15/2020
Guangdong Longtai Industry Co., Ltd. (China)​
Vertra Hand Sanitizer Topical Solution ​
52807-103-01
52807-103-02
52807-103-03
52807-103-04
52807-103-05
52807-103-06
52807-103-07
52807-103-08
52807-103-09
52807-103-10
EAI-JR286 Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/05/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ssential” Hand Sanitizer
52807-002-01
52807-003-01
52807-004-01
52807-005-01
52807-006-01
52807-007-01
52807-008-01
52807-009-01
52807-010-01
52807-011-01
52807-012-01
52807-013-01
52807-014-01
LLF Phoenix LLC
(Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ssential” Aloe Vera Gel Hand Sanitizer
52807-015-01
52807-016-01
52807-017-01
52807-018-01
52807-019-01
52807-020-01
LLF Phoenix LLC
(Nevada)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
“ts” By Tara - Clean Up Hand Sanitizer
52807-021-01
52807-021-02
52807-021-03
Guangdong Longtai Industry Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Eco-Planet Pura Advanced Hand Sanitizer
52807-001-01
Guangdong Longtai Industry Co., Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Spa Da Health
PROmmunity Hand Sanitizer
52807-022-01
52807-022-02
Accel Inc.
(Ohio)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Healing Solutions Premium Hand Sanitizer
52807-101-01
52807-101-02
52807-101-03
52807-101-04
52807-101-05
52807-101-06
52807-101-07
52807-101-08
52807-101-09
52807-101-10
52807-101-11
52807-101-12
52807-101-13
52807-101-14
52807-101-15
52807-101-16
52807-101-17
52807-101-18
52807-101-19
52807-101-20
52807-101-21
52807-101-22
52807-101-23
52807-101-24
52807-101-25
52807-101-26
52807-101-27
52807-101-28
52807-101-29
52807-101-30
52807-101-31
52807-101-32
52807-101-33
52807-101-34
52807-101-35
52807-101-36
52807-101-37
52807-101-38
52807-101-39
52807-101-40
52807-101-41
52807-101-42
52807-101-43
52807-101-44
52807-101-45
Healing Solutions LLC
(Arizona)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangdong Longtai Industry Co., Ltd. (China)
Roots Aromatherapy Hand Sanitizer
52807-102-01
52807-102-02
52807-102-03
52807-102-04
52807-102-05
52807-102-06
52807-102-07
52807-102-08
52807-102-09
52807-102-10
52807-102-11
52807-102-12
52807-102-13
52807-102-14
52807-102-15
52807-102-16
52807-102-17
52807-102-18
52807-102-19
52807-102-20
52807-102-21
52807-102-22
52807-102-23
52807-102-24
52807-102-25
52807-102-26
52807-102-27
52807-102-28
52807-102-29
52807-102-30
52807-102-31
52807-102-32
52807-102-33
52807-102-34
52807-102-35
52807-102-36
52807-102-37
52807-102-38
52807-102-39
52807-102-40
52807-102-41
52807-102-42
52807-102-43
52807-102-44
52807-102-45
52807-102-46
52807-102-47
52807-102-48
52807-102-49
52807-102-50
52807-102-51
52807-102-52
52807-102-53
52807-102-54
52807-102-55
Hotel Emporium Inc
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China)
Cisimonn
No-washing Disinfection Gel
78278-102-01
78278-102-02
78278-102-03
78278-102-04
78278-102-11
78278-102-12
78278-102-13
78278-102-14
78278-102-15
Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Hand Sanitizer
74447-012-01
Guangzhou Minghui Cosmetics Co. Ltd.
FDA tested product; ethyl alcohol level was subpotent; added to
import alert
to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a
warning letter
on 07/06/2021.
04/12/2021
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Hand Sanitizer
74447-001-01
74447-002-01
74447-003-01
74447-004-01
74447-005-01
74447-006-01
74447-007-01
74447-008-01
74447-009-01
74447-010-01
74447-011-01
74447-012-02
74447-012-03
74447-012-04
74447-012-05
74447-012-06
74447-012-07
74447-012-08
74447-012-09
74447-012-10
Guangzhou Minghui Cosmetics Co. Ltd.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to
import alert
to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a
warning letter
on 07/06/2021.
04/12/2021
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Medical Alcohol Disinfectant
74447-101-01
74447-101-02
74447-101-03
74447-101-04
74447-101-05
74447-101-06
74447-101-07
74447-101-08
74447-101-09
74447-101-10
74447-101-11
74447-101-12
74447-101-13
74447-101-14
74447-101-15
74447-101-16
74447-101-17
Guangzhou Minghui Cosmetics Co. Ltd.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to
import alert
to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a
warning letter
on 07/06/2021.
04/12/2021
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Waxman Kleen Freak Hand Sanitizer
74447-106-01
Waxman Industries
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to
import alert
to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a
warning letter
on 07/06/2021.
04/12/2021
Guangzhou Youxing Cosmetics Co. Ltd.(China)
V&W Advance Hand Sanitizer Refreshing Gel
75239-005-09
Val USA Manufacturer Inc.
FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021
10/01/2020
Guangzhou Youxing Cosmetics Co. Ltd. (China)
V&W Advance Hand Sanitizer Refreshing Gel
75239-005-01
75239-005-02
75239-005-03
75239-005-04
75239-005-05
75239-005-06
75239-005-07
75239-005-08
75239-005-10
75239-005-11
75239-005-12
75239-005-13
75239-005-14
75239-005-15
75239-005-16
75239-005-17
Val USA Manufacturer Inc.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021
10/01/2020
Guangzhou Youxing Cosmetics Co. Ltd. (China)
V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.]
75239-006-01
75239-006-02
75239-006-03
75239-006-04
75239-006-05
75239-006-06
75239-006-07
75239-006-08
75239-006-09
75239-006-10
75239-006-11
75239-006-12
75239-006-13
75239-006-14
75239-006-15
75239-006-16
75239-006-17
75239-006-18
75239-006-19
75239-006-20
Val USA Manufacturer Inc.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021.
10/01/2020
Guangzhou Youxing Cosmetics Co. Ltd. (China)
V&W Premium Disinfecting Wipes
75239-007-01
Val USA Manufacturer Inc.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021.
10/01/2020
Guangzhou Youxing Cosmetics Co. Ltd. (China)
V&W Advance Hand Sanitizer Refreshing Gel
76687-005-01
76687-005-02
76687-005-03
76687-005-04
76687-005-05
76687-005-06
76687-005-07
76687-005-08
76687-005-09
76687-005-10
76687-005-11
76687-005-12
76687-005-13
76687-005-14
76687-005-15
76687-005-16
76687-005-17
76687-005-18
76687-005-19
76687-005-20
Val USA Manufacturer Inc.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021.
10/01/2020
Guangzhou Youxing Cosmetics Co. Ltd. (China)
V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.]
76687-006-01
76687-006-02
76687-006-03
76687-006-04
76687-006-05
76687-006-06
76687-006-07
76687-006-08
76687-006-09
76687-006-10
76687-006-11
76687-006-12
76687-006-13
76687-006-14
76687-006-15
76687-006-16
76687-006-17
76687-006-18
76687-006-19
76687-006-20
Val USA Manufacturer Inc.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/8/2020; FDA issued a
warning letter
on 09/30/2021.
10/01/2020
Guangzhou Minghui Cosmetics Co. Ltd. (China)
Qi Yu Hand Sanitizer
74447-010-01
Guangzhou Minghui Cosmetics Co. Ltd.
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to
import alert
to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a
warning letter
on 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021
7/21/2021
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Cloudz instant hand sanitizer
74935-020-00
74935-020-01
79860-020-00
79860-020-01
Solaray, LLC (Oklahoma)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Artnaturals Hand Sanitizer Infused with Jojoba Oil
74935-016-00
74935-018-00
78706-016-00
78706-018-00
Artnaturals (California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Orchard De Flore Instant Hand Sanitizer
74935-015-00
74935-015-01
78733-015-00
78733-015-01
Sonora Corp. (California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Premium Nature Hand Sanitizer
74935-010-04
74935-010-08
Premium Nature (New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Artnaturals Hand Sanitizer Scent Free
74642-002-00
74935-002-00
Artnaturals
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Germ Free Anti-Bacterial Instant Hand Sanitizer
74935-003-00
76782-003-00
Blue Mineral Corporation
(New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Purago Advanced Hand Sanitizer
74935-004-00
74935-012-00
76812-004-00
76812-009-00
Puraall, LLC
(Georgia)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
CB Advanced Hand Sanitizer
74935-005-00
74935-014-00
76813-005-00
76813-014-00
CB Distributors, Inc.
(Wisconsin)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Orchard De Flore Instant Hand Sanitizer
74935-006-00
74935-006-01
74935-006-02
74935-006-03
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
True Wash Instant Hand Sanitizer
74935-007-00
74935-007-01
74935-007-02
74935-007-03
75478-007-00
75478-007-01
75478-007-02
75478-007-03
Supply Chain Sources, LLC
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Eluo Advanced Hand Sanitizer with Aloe
74935-008-00
76869-008-00
Titan TD, Inc
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Apollo Instant Hand Sanitizer Anti Bacterial
74935-009-00
Apollo Distributors
(Texas)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
SureSafe Handsanitizer Gel with Aloe
74935-011-00
74935-011-01
78111-010-00
78111-010-01
JAB Holdings, LLC
(Hawaii)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Health & Wellness Essentials Hand Sanitizer Wash-Free
74935-017-00
Health & Wellness Essentials, Inc
(California)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
New Sanicol Advanced Antibacterial Hand Sanitizer
74935-019-00
79254-019-00
AM Beauty Distributors
(New York)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
Uncle Jed’s Cold Remedy Hand Sanitizer
74935-021-01
81172-000-01
Earth Sense Energy Systems, Inc
(Wisconsin)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd
(China)
EA Instant Hand Sanitizer
74935-013-00
74935-013-01
74935-013-02
74935-013-03
74935-013-04
78233-013-00
78233-013-01
78233-013-02
78233-013-03
78233-013-04
National Travel Products, Inc (New Jersey)
Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 5/16/2022; FDA issued a
warning letter
on 07/20/2022.
06/08/2022
Harmonic Nature S de RL de MI (Mexico)
Alcohol Antiseptic 75% Topical Solution Hand Sanitizer
76949-234-01
76949-234-02
76949-235-01
76949-235-02
FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/20/2020; product voluntarily
recalled
on 8/14/2020; FDA issued a
warning letter
on 11/16/2020
08/12/2020
Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico)
HF&N Lab Medi Care Alcohol Antiseptic Topical Solution
77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02
Healthy Food and Nutrition Lab
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 09/29/2021
07/30/2020
Hou Fu Biotech (Jiansu) Co. Ltd. (China)
PANROSA Instant Hand Sanitizer Aloe Vera
76766-001-01
Panrosa Enterprise Inc.
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/3/2020; FDA issued a
warning letter
on 4/12/2021
11/13/2020
Hou Fu Biotech (Jiansu) Co. Ltd. (China)
PANROSA Instant Hand Sanitizer Aloe Vera
50302-013-10
50302-013-60
50302-020-50
76766-001-02
76766-001-03
Panrosa Enterprise Inc
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/3/2020; FDA issued a
warning letter
on 4/12/2021
11/13/2020
Hou Fu Biotech (Jiansu) Co. Ltd. (China)
PANROSA Instant Hand Sanitizer
50302-003-00
50302-003-11
50302-003-60
50302-021-50
76766-000-01
76766-000-02
76766-000-03
Panrosa Enterprise Inc
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/3/2020; FDA issued a
warning letter
on 4/12/2021
11/13/2020
Hou Fu Biotech (Jiansu) Co. Ltd. (China)
EPH Labs Hand Sanitizer
76766-002-01
76766-002-02
76766-002-03
76766-002-04
EPH Labs
Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 12/3/2020; FDA issued a
warning letter
on 4/12/2021
11/13/2020
Ignacio Reyes Gonzalez (Mexico)
Medically Minded Hand Sanitizer Gel Antimicrobial Formula
77196-003-01
SBL Brands LLC dba Global Sanitizers LLC (Nevada)
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/21/2020; FDA issued a
warning letter
on 1/25/2021
08/13/2020
Ignacio Reyes Gonzalez (Mexico)
Alcohol Antiseptic 70% Solution or 80% Solution
77196-001-02
77196-001-05
77196-001-06
77196-001-07
77196-001-08
77196-002-01
77196-002-02
77196-002-03
77196-002-04
77196-002-05
77196-002-06
77196-002-07
77196-002-08
77196-002-09
77196-002-10
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/21/2020; FDA issued a
warning letter
on 1/25/2021
08/13/2020
Incredible Products SA de CV (Mexico)
GelBac T Hand Sanitizer
71761-000-00
Pacific Coast Global Inc. and Tritanium Labs LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily
recalled
on 8/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 05/27/2021
07/30/2020
Incredible Products SA de CV (Mexico)
Hand Sanitizer
71761-000-01
71761-000-05
71761-000-10
71761-000-20
71761-000-22
71761-000-37
71761-000-99
Pacific Coast Global Inc. and Tritanium Labs LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 05/27/2021
07/30/2020
Incredible Products SA de CV (Mexico)
TriCleanz (labeled with “Made in Mexico”)
71761-001-00
Tritanium Labs LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 05/27/2021
07/30/2020
Incredible Products SA de CV (Mexico)
TriCleanz Tritanium Labs Hand Sanitizer (labeled with “Made in Mexico”)
77757-111-01
Tritanium Labs LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 05/27/2021
07/30/2020
Industrias Cklass S de RL de CV (Mexico)
Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents
76528-420-10
Industrias Cklass S de RL de CV
FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/14/2020; FDA issued a
warning letter
on 06/22/2022
09/08/2020
Industrias Cklass S de RL de CV (Mexico)
Industrias Cklass Foaming Hand Sanitizer with Aloe
76528-420-01
76528-420-02
76528-420-03
76528-420-04
Wizard Creations Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/14/2020; FDA issued a
warning letter
on 06/22/2022
09/08/2020
Inovaker Lab SA de CV (Mexico)
Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution
77271-002-01
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/2/2020; FDA issued a
warning letter
on 2/25/2021
09/24/2020
Inovaker Lab SA de CV (Mexico)
El Bueno Hand Sanitizer
75719-002-02
Fiesta Union S de RL de CV
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/2/2020; FDA issued a
warning letter
on 2/25/2021
09/24/2020
Inovaker Lab SA de CV (Mexico)
Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%
77271-001-01
77271-001-02
77271-001-03
77271-001-04
77271-001-05
77271-001-06
77271-001-07
77271-002-02
77271-002-03
77271-002-04
77271-002-05
77271-002-06
Inovaker Lab SA de CV
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/2/2020; FDA issued a
warning letter
on 2/25/2021
09/24/2020
Inovaker Lab SA de CV (Mexico)
EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer
77858-0750-1
77858-0751-1
77858-0752-1
77858-0755-1
77858-0755-2
Sayida Group
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/2/2020; FDA issued a
warning letter
on 2/25/2021
09/24/2020
Inovaker Lab SA de CV (Mexico)
Inovaker Hand Sanitizer
78106-002-01
78106-002-02
78106-002-03
78106-002-06
78106-002-07
UH Group LLC
Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 10/2/2020; FDA issued a
warning letter
on 2/25/2021
09/24/2020
Ismar Soluciones Dinámicas S de RL de CV (Mexico)
OZO Hand Sanitizer
Not listed
Ancorp Capital Group USA
Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/14/2020
08/06/2020
Ismar Soluciones Dinámicas S de RL de CV (Mexico)
OZO Ozone Hand sanitizer Gel
77210-0012-1
77210-0012-2
77210-0012-3
77210-0012-4
JS Global Sourcing
Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/14/2020
08/13/2020
Ismar Soluciones Dinámicas S de RL de CV (Mexico)
Goldsquare Hand Sanitizer
77210-0009-1
77210-0013-1
Exportadora In & Out de RL de CV
Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/14/2020
08/13/2020
Ismar Soluciones Dinámicas S de RL de CV (Mexico)
Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel
77210-0010-1
Exportadora In & Out de RL de CV
Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/14/2020
08/13/2020
JG Atlas Comercios SA de CV (Mexico)
Sayab Antisepctic Hand Sanitizer 100
75292-001-00
JG Atlas Comercios
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/7/2020; FDA issued a
warning letter
on 11/6/2020
07/30/2020
Jose Miguel Gutierrez Salas (Mexico)
MVP Sanitizing Services Spray Hand Sanitizer
76947-198-20
76947-198-21
76947-199-21
SNS Distribution LLC
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/1/2020; FDA issued a
warning letter
on 07/21/2022.
08/19/2020
Laboratorios Jaloma SA de CV (Mexico)
Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E
65055-600-00
65055-600-01
65055-600-02
Laboratorios Jaloma SA de CV
FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily
recalled
on 7/31/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/3/2020; FDA issued a
warning letter
on 1/25/2021
07/24/2020
Leiper’s Fork Distillery (Tennessee)
Leiper’s Fork Distillery Bulk Disinfectant per 5 gallon and Leiper’s Fork Distillery 16 oz bottle
Not listed
Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020
07/24/2020
Limpo Quimicos SA de CV (Mexico)
Andy’s Best
73755-120-01
73755-120-02
73755-120-04
Brand Name Distributors
FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 09/30/2021
07/08/2020
Limpo Quimicos SA de CV (Mexico)
Andy’s
73755-110-01
73755-130-02
Brand Name Distributors
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 09/30/2021
07/08/2020
Limpo Quimicos SA de CV (Mexico)
NeoNatural
73755-200-01
73755-200-02
Brand Name Distributors
FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 09/30/2021
07/08/2020
Limpo Quimicos SA de CV (Mexico)
Plus Advanced
73755-300-01
Brand Name Distributors
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 09/30/2021
07/08/2020
Liqesa Exportacion or Liq-E-SA de CV (Mexico)
Optimus Instant Hand Sanitizer
75416-001-04
Liq-E SA de CV
FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; product voluntarily
recalled
on 7/20/2020; FDA issued a
warning letter
on 11/19/2020
07/21/2020
Liqesa Exportacion or Liq-E-SA de CV (Mexico)
Optimus Lubricants Instant Hand Sanitizer
75416-005-01
Liq-E SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA issued a
warning letter
on 11/19/2020
07/08/2020
Liqesa Exportacion or Liq-E-SA de CV (Mexico)
Optimus Instant Hand Sanitizer
75416-002-01
75416-004-01
75416-378-04
Liq-E SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; product voluntarily
recalled
on 7/20/2020; FDA issued a
warning letter
on 11/19/2020
07/21/2020
Maquiladora Miniara SA de CV (Mexico)
Shine and Clean Hand Sanitizer
76753-001-01
76753-001-02
76753-001-03
Maquiladora Miniara SA de CV
FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily
recalled
on 7/9/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020. FDA issued a
warning letter
on 12/15/2021
07/10/2020
Maquiladora Miniara SA de CV (Mexico)
Selecto Hand Sanitizer
76753-002-01
Bodega Latina Corp.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020. FDA issued a
warning letter
on 12/15/2021
07/10/2020
Mirfeel Korea Co., Ltd. (Korea)
The Crème Shop Moisturizing Hand Sanitizer, Peppermint Scented
75010-130-01
The Crème Shop (California)
FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
02/23/2022
Mirfeel Korea Co., Ltd. (Korea)
Moisturizing Hand Sanitizer –
Mixed Berries Scented
Green Tea Scented 500mL
Hello Kitty Watermelon Scent
Hello Kitty Strawberry Scent
Eucalyptus Scented
Green Tea Scented 60mL
Green Tea Scented Towlettes
Hello Kitty Candy Apple Scent
Gudetama Peach Scent
75010-020-01
75010-030-01
75010-050-01
75010-060-01
75010-070-01
75010-080-01
75010-090-01
75010-110-01
75010-120-01
The Crème Shop (California)
Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
04/13/2022
Mirfeel Korea Co., Ltd. (Korea)
AOMI Hand Sanitizer Gel and Spray
75010-010-01
75010-040-01
75010-140-01
Mirfeel Korea Co., Ltd. (Korea)
Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
04/13/2022
Mirfeel Korea Co., Ltd. (Korea)
CoSo Health Hand Sanitizer
75010-100-01
CoSo Health (Colorado)
Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
04/13/2022
Mirfeel Korea Co., Ltd. (Korea)
TerraPure Hand Sanitizer
75010-150-01
75010-150-02
75010-150-03
TerraPure Sanitizer Inc. (Canada)
Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
04/13/2022
Mirfeel Korea Co., Ltd. (Korea)
Instant Hand Sanitizer
with natural extracts
Instant Hand Sanitizer Wipes
74443-010-15
74443-010-50
74443-020-05
74443-020-50
74443-030-01
74443-030-05
The Australian Wellness Co (Australia)
Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a
warning letter
on 06/22/2022
04/13/2022
MXL Comercial SA de CV (Mexico)
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
77106-002-01
Resource Recovery and Trading LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/24/2020; product voluntarily
recalled
on 7/27/2020; FDA issued a
warning letter
on 11/10/2020
07/15/2020
MXL Comercial SA de CV (Mexico)
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub
77106-001-01
77106-001-02
77106-001-03
77106-001-04
77106-001-05
77106-001-06
77106-001-07
77106-001-08
Resource Recovery and Trading LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/24/2020; product voluntarily
recalled
on 7/27/2020; FDA issued a
warning letter
on 11/10/2020
07/15/2020
MYM Hidrominerales SA de CV (Mexico)
Protz Real Protection Antibacterial Hand Sanitizer
77872-600-40
Safety-Med Products Inc.
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/27/2020; FDA issued a
warning letter
on 4/9/2021
08/17/2020
Mystic International SA de CV (Mexico)
Mystic Shield Protection hand sanitizer
75477-435-02
75477-435-10
75477-435-12
75477-435-25
75477-435-50
75477-534-10
Transliquid Technologies LLC
Company tested product; contains methanol; product voluntarily recalled by
Transliquid Technologies LLC
on 7/2/2020
07/02/2020
Nanomateriales SA de CV (Mexico)
Zanilast + Gel
69912-006-01
Nanomateriales SA de CV
FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily
recalled
on 8/26/2020; added manufacturer to
import alert
(66-78) to help stop their products from entering the U.S. on 8/31/2020; added to
import alert
(66-40) on 1/12/2021; FDA issued a
warning letter
on 09/15/2021
08/17/2020
Nanomateriales SA de CV (Mexico)
Zanilast + Gel
69912-008-01
69912-008-02
69912-009-03
69912-009-04
69912-009-05
69912-009-06
Fujimura Trading SA de CV
Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily
recalled
on 8/26/2020; added manufacturer to
import alert
(66-78) to help stop their products from entering the U.S. on 8/31/2020; added to
import alert
(66-40) on 1/12/2021; FDA issued a
warning letter
on 09/15/2021
08/17/2020
Neoingenium Labs SA de CV Hand sanitizer (Mexico)
CleansePure 70% Alcohol
77031-505-01
Distribu LLC
FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/18/2020; FDA issued a
warning letter
on 3/31/21
09/11/2020
Neoingenium Labs SA de CV Hand sanitizer (Mexico)
ProCare Gel
75810-101-01
Neoingenium Labs SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/18/2020; FDA issued a
warning letter
on 3/31/21
09/11/2020
Neoingenium Labs SA de CV Hand sanitizer (Mexico)
Hand Sanitizer
75810-102-01
Frozen Wheels LLC (Miami)
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/18/2020; FDA issued a
warning letter
on 3/31/21
09/11/2020
Neoingenium Labs SA de CV Hand sanitizer (Mexico)
SafeMedics
75810-103-01
75810-103-04
75810-103-05
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/18/2020; FDA issued a
warning letter
on 3/31/21
09/11/2020
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Marvel Spiderman Hand Sanitizer
74530-046-01
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Hand Sanitizer
Kills Germs
74530-042-01
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Hand Sanitizer
74530-041-01
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Disney Princess Hand Sanitizer
74530-015-01
74530-015-02
74530-015-03
74530-015-04
74530-015-05
74530-015-06
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Disney Frozen II Hand Sanitizer
74530-011-01
74530-011-02
74530-011-03
74530-011-04
74530-011-05
74530-011-06
74530-011-07
74530-011-08
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Disney Mickey Mouse Hand Sanitizer
74530-013-01
74530-013-03
74530-013-04
74530-013-05
74530-013-06
74530-013-07
74530-013-08
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Disney Mickey Mouse Hand Sanitizer
74530-013-02
Best Brand Consumers Products, Inc. (New York)
FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily
recalled
lot 20D21 on 4/1/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/02/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations
74530-012-01
74530-012-03
74530-012-04
74530-012-05
74530-012-06
74530-012-07
74530-012-08
Best Brand Consumers Products, Inc. (New York)
Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/09/2022
Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China)
Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations
74530-012-02
Best Brand Consumers Products, Inc. (New York)
FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily
recalled
lot 20E21 on 4/1/2022; added manufacturer to
import alert
to help stop their products from entering the U.S. on 4/22/2022
03/02/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Instant Hand Sanitizer Aloe & Moisturizers
52903-001-01
52903-002-01
52903-003-01
52903-004-01
52903-005-01
52903-051-01
52903-052-01
52903-053-01
52903-054-01
52903-055-01
52903-100-01
52903-101-01
52903-201-01
52903-301-01
52903-401-01
52903-501-01
52903-501-91
52903-502-01
52903-502-91
The BIGBOND LLC
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Alcohol Antiseptic 80%
Hand Rub
59203-500-01
The BIGBOND LLC
(New Jersey
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Delma Instant Hand Sanitizer Gel
80208-111-01
80208-111-02
80208-111-03
80208-111-04
80208-111-05
Delma Global Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Delma Instant Hand Sanitizer Gel
With Aloe Vera
80208-112-01
80208-112-02
80208-112-03
80208-112-04
Delma Global Inc.
(California)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Instant Hand Sanitizer Aloe & Moisturizers
87052-003-02
87052-004-01
87052-005-01
87052-005-02
87052-007-01
87052-008-01
87052-009-01
87052-010-01
87052-013-01
87052-111-01
87052-115-01
87052-117-01
87052-119-01
The BIGBOND LLC
(New Jersey)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Ningbo Pasco United Industry Co., Ltd. (China)
Pasco Alcohol Antiseptic 80%
Hand Rub
80752-500-01
The BIGBOND LLC
(New Jersey)*
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 07/06/2022
06/08/2022
Notarika SA de CV (Mexico)
Greenfrog Hand Sanitizer
77031-454-05
77031-454-34
77145-000-01
77145-000-02
Notarika SA de CV
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 10/07/2021
08/03/2020
Notarika SA de CV (Mexico)
Greenfrog Hand Sanitizing wipes
77145-001-00
77145-001-01
77145-001-02
77145-001-03
77145-002-03
Notarika SA de CV
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA issued a
warning letter
on 10/07/2021
08/03/2020
Noticias Mexico Hoy Grupo Multimedia (Mexico)
Medical Mary Clean Hand Sanitizer
76839-521-01
76839-521-04
76839-522-03
Medical Mary LLC
FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/21/2020; FDA issued a
warning letter
on 06/27/2022
08/06/2020
Noticias Mexico Hoy Grupo Multimedia (Mexico)
AMX Instant Hand Sanitizer
76839-523-05
AMX Premium Cleaning Services LP
Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/21/2020; FDA issued a
warning letter
on 06/27/2022
08/06/2020
Nutrix International LLC
Heal the World LLC
73333-285-01
Heal the World hand sanitizer
Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily
recalled
on 3/16/2021
03/08/2021
Open Book Extracts (North Carolina)
Always Be Clean Hand Sanitizer
75091-2020-1
75091-2020-2
75091-2020-3
Open Book Extracts
Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily
recalled
on 8/29/2020
08/11/2020
Open Book Extracts (North Carolina)
Just Hand Sanitizer Single Use Packs
78065-2020-1
78065-2020-2
Just Hand Sanitizer
Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily
recalled
on 8/29/2020
08/11/2020
Plasticos Las Palmas SA de CV (Mexico)
BV BYE Virus 99
76560-0001-2
76560-0001-3
76560-0001-4
76560-0001-5
76560-0001-6
76560-0001-8
Comercial Goura S de RL and S&L Brands
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/6/2020; FDA issued a
warning letter
on 3/1/2021
08/11/2020
Plasticos Las Palmas SA de CV (Mexico)
In Good Hands Hand Sanitizer Gel
76560-0002-1
76560-0002-2
76560-0002-3
Admay Consulting LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/6/2020; FDA issued a
warning letter
on 3/1/2021
08/11/2020
Prairie Wolf Spirits
Prairie Wolf Distillery Hand Sanitizer
73891-1001-4
73891-1001-5
73891-1002-4
73891-1002-5
Prairie Wolf Spirits
Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product
recalled
on 06/21/2021
06/23/2021
Precision Analitica Integral SA de CV (Mexico)
CleanCare Nogerm Advanced Hand Sanitizer
77492-006-25
77492-007-01
77492-008-50
77492-009-05
ESPMEX LLC
FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 2/5/2021
08/07/2020
Quimica Magna de Mexico SA de CV (Mexico)
Datsen Hand Sanitizer
Not listed
FDA tested product; ethyl alcohol level was subpotent; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a
warning letter
on 10/15/2020
08/03/2020
Quimica Magna de Mexico SA de CV (Mexico)
Alcohol Antiseptic 62% Hand Sanitizer
74844-162-02
74844-162-08
74844-162-17
74844-162-34
Quimica Magna de Mexico SA de CV
FDA tested product; ethyl alcohol level was subpotent; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a
warning letter
on 10/15/2020
08/03/2020
Quimica Magna de Mexico SA de CV (Mexico)
Bernal Hand Sanitizer
74541-270-01
74541-270-02
74541-270-04
74541-270-06
74541-270-08
74541-270-17
74541-270-34
74541-270-37
Inflatables LLC
Product purported to be made at the same facility that produced subpotent product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a
warning letter
on 10/15/2020
08/03/2020
Quimica Magna de Mexico SA de CV (Mexico)
Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer
74844-165-02
74844-165-08
74844-165-17
74844-165-34
74844-170-02
74844-170-08
74844-170-17
74844-170-34
Inflatables LLC
Product purported to be made at the same facility that produced subpotent product; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/15/2020; FDA recommended the company recall on 7/16/2020; FDA issued a
warning letter
on 10/15/2020
08/03/2020
Real Clean Distribuciones SA de CV (Mexico)
Born Basic. Anti-Bac Hand Sanitizer 70% alcohol
76891-104-11
76891-104-12
76891-104-13
76891-104-14
76891-104-15
76891-104-16
76891-104-17
76891-104-18
76891-104-19
73389-104-11
Scent Theory Products LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/23/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
Born Basic. Anti-Bac Hand Sanitizer 65% Alcohol
76891-105-11
76891-105-12
76891-105-13
76891-105-14
76891-105-15
76891-105-16
76891-105-17
76891-105-18
76891-105-19
76891-105-20
Scent Theory Products LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer
76891-102-11
Scent Theory Products LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/23/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
Cavalry (labeled with “Product of Mexico”)
75460-070-01
75460-070-02
75460-070-05
Cavalry Sanitizers LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
ENLIVEN Hand Sanitizing Gel
74882-341-01
74882-341-02
74882-341-03
Procurement Services LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
Lux Eoi Hand Sanitizing Gel
74882-007-01
74882-007-02
74882-007-03
Procurement Services LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/23/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Real Clean Distribuciones SA de CV (Mexico)
Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer
73389-102-11
Scent Theory Products Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/16/2020; product voluntarily
recalled
on 7/23/2020; FDA issued a
warning letter
on 10/27/2020
07/14/2020
Rodriguez Fierro, Marco Antonio (Mexico)
Natural Gold Gel Alcohol Antiseptic 75% Topical Solution
78368-567-12
Dist. de Prod. Alim. El Paisita
FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/28/2020
09/17/2020
Roque Plast SA de CV (Mexico)
Command Gel AntiBac Instant hand sanitizer
50058-100-08
Roque Plast SA de CV
FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily
recalled
8/4/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/13/2020; FDA issued a
warning letter
on 4/9/2021
08/03/2020
S-One Pharmaceutical Inc
(Korea)
Safe Cleaner Hand Sanitizer Gel
Sophora Extract
Mint Oil
Grapefruit Extract
74721-0001-1
74721-0001-2
74721-0001-3
74721-0001-4
74721-0001-5
74721-0001-6
74721-0001-7
74721-0001-8
74721-0001-9
74721-0001-0
74721-0002-1
74721-0002-2
74721-0002-3
74721-0002-4
74721-0002-5
74721-0002-6
74721-0002-7
74721-0002-8
74721-0002-9
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-One Pharmaceutical Inc
(Korea)
Safe Cleaner K
Disinfection Spray Chlorine Dioxide Ion (1-)
74721-0050-1
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose)
80969-006-01
80969-007-01
80969-008-01
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Protection For All Hand Sanitizer
80969-010-01
80969-010-02
80969-010-06
80969-010-07
80969-020-03
80969-020-04
80969-040-03
80969-040-04
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
PFA Stronghold Hand Sanitizer
Alcohol Free Disinfectant
80969-030-02
Stronghold Trading, LLC
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
NYC HEALTH HOSPITALS HAND SANITIZER
80969-050-01
80969-050-02
Stronghold PFA
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
S-ONE Pharmaceutical Inc. (Korea)
Safe Cleaner Plus
Sophora Extract
Mint Oil
Grapefruit Extract
74721-0010-1
74721-0010-2
74721-0010-4
74721-0010-5
74721-0010-6
74721-0010-7
74721-0010-8
74721-0010-9
74721-0020-0
74721-0020-1
74721-0020-2
74721-0020-5
74721-0020-6
74721-0020-7
74721-0020-8
74721-0020-9
S-ONE Pharmaceutical Inc. (Korea)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/12/2022
06/29/2022
Santa Cruz Biotechnology (Texas)
UltraCruz Hand Sanitizing Gel Antimicrobial
90032-214-08
90032-214-83
90032-214-94
Santa Cruz Biotechnology
Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020
08/11/2020
Sanit Technologies LLC, doing business as Durisan (Florida)
Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free
71120-112-01
71120-112-05
71120-112-06
71120-112-08
71120-112-10
71120-112-11
71120-611-07
71120-611-08
71120-612-06
71120-612-07
71120-117-02
Sanit Technologies LLC, dba Durisan
Company tested product; contains microbial contamination; product
recalled
to wholesale level on 3/24/2021;
recall expanded
on 4/10/2021;
recall expanded
on 5/14/2021;
recall expanded
on 06/19/2021
03/25/2021
Sanit Technologies LLC, doing business as Durisan (Florida)
Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free
71120-111-01
71120-111-02
71120-111-03
Sanit Technologies LLC, dba Durisan
Company tested product; contains microbial contamination; product
recalled
on 3/24/2021;
recall expanded
on 4/10/2021;
recall expanded
on 5/14/2021;
recall expanded
on 06/19/2021
05/19/2021
Sanitor Corporation (California)
New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%)
80042-003-00
New Wave Cleaning Solutions LLC
Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. FDA recommended the company recall on 9/20/2021; product voluntarily recalled on 9/21/2021
09/22/2021
SBL Brands LLC dba Global Sanitizers, LLC (Nevada)
American Screening HAND SANITIZER
Not listed
American Screening, LLC
Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a
warning letter
on 11/08/2021. product voluntarily
recalled
on 11/19/2021
09/29/2021
Scentsational Soaps and Candles Inc. (Florida)
Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution
75078-002-01
75078-003-01
75078-004-01
Scentsational Soaps and Candles Inc.
Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily
recalled
on 4/28/2021;
recall expanded
on 5/10/2021
04/29/2021
Scentsational Soaps and Candles Inc. (Florida)
Fresh Lemon Citron Frais Scented Hand Sanitizer
Not Listed
Ulta Beauty
Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily
recalled
on 4/28/2021;
recall expanded
on 5/10/2021
05/03/2021
Scentsational Soaps and Candles Inc. (Florida)
SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava
Not Listed
Scentsational Soaps and Candles Inc.
Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily
recalled
on 4/28/2021;
recall expanded
on 5/10/2021
05/03/2021
Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey)
Neutrevo Instant Hand Sanitizer
86818-002-06
Leather Links Inc.
FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/22/2020; FDA issued a
warning letter
on 07/15/2021
09/11/2020
Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey)
Neutrevo Instant Hand Sanitizer
86818-002-05
86818-002-07
86818-002-08
Leather Links Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/22/2020; FDA issued a
warning letter
on 07/15/2021
09/11/2020
Sck Zeta Zimya (Turkey)
Neutrevo Alcohol Wet Wipes
86818-005-01
86818-005-02
86818-005-03
86818-005-04
86818-005-05
86818-005-06
Sck Zeta Dis Ticaret Pazarlama Ltd.
Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to
import alert
to help stop their products from entering the U.S. on 9/22/2020; FDA issued a
warning letter
on 07/15/2021
09/11/2020
SG24 LLC (Georgia)
SkinGuard24 All-Day Hand Sanitizer
Not listed
Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily
recalled
on 8/14/2020
08/11/2020
Shuzy Rock, Inc. (New Jersey)
Premium Nature Instant Hand Sanitizer
75821-001-01
75821-001-02
75821-001-03
75821-001-04
75821-002-01
75821-002-02
75821-002-03
Premium Nature
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022
01/24/2022
Signature Formulations, LLC (Arizona)
Sigform Cares Hand Sanitizer
Not Listed
Signature Formulations, LLC (Arizona)
Company tested product; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022 Associated lot numbers:
200401143;
200406143;
200414145;
200415145;
200422145;
200522148;
200611145.
04/13/2022
Signature Formulations, LLC (Arizona)
BIOLabs PRO Killshot Hand Sanitizer
Not Listed
Signature Formulations, LLC (Arizona)
Company tested product lot 200423322; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022.
04/13/2022
Signature Formulations, LLC (Arizona)
Cultivation Republic Hand Sanitizer
Not Listed
Cultivation Republic (Clearwater, Florida)
Company tested product lot 2004090090; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022.
04/13/2022
Simex Logistics SA de CV (Mexico)
Health & Hand Gel Hand Sanitizer
78247-006-01
Blue Ridge Southern Supply LLC
FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Simex Logistics SA de CV (Mexico)
Health & Hand Gel Hand Sanitizer
78247-007-10
Blue Ridge Southern Supply LLC
Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Simex Logistics SA de CV (Mexico)
LAVAR70 Gel Hand Sanitizer
78247-001-01
Blue Ridge Southern Supply LLC
Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Simex Logistics SA de CV (Mexico)
CitruGel Hand Sanitizer
78247-002-01
CitruGel Inc.
Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Simex Logistics SA de CV (Mexico)
UVTWORLD Gel Hand Sanitizer
78247-003-01
UVT World
Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Simex Logistics SA de CV (Mexico)
Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution
78247-004-01
78247-005-05
78247-008-10
PS Promotional Services LLC
Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 11/17/2020; product voluntarily recalled on 11/25/2020; FDA issued a
warning letter
on 1/28/2021
11/10/2020
Soleo Cosmetic Co. Ltd. (Korea)
Smart Care hand sanitizer packaged in 0.84 fl oz. containers resembling food pouches labeled with children’s characters, including Barbie, Hot Wheels, Paw Patrol, Minions, JoJo Siwa Dreamer and Trolls World Tour
70108-042-01
71693-007-01
70108-043-01
71693-008-01
70108-044-01
71693-004-01
70108-045-01
71693-005-01
70108-046-01
71693-006-01
70108-047-01
71693-009-01
Ashtel Studios Inc.
Hand sanitizer products packaged in containers resembling food pouches commonly used for children’s applesauce and other pureed foods that present increased risk of accidental ingestion by children; FDA recommended the distributor recall on 9/21/2020; this advisory does not extend to Smart Care products in other types of packaging; product voluntarily
recalled
by Ashtel on 10/1/2020 (includes product photos)
09/24/2020
Spartan Chemical Co Inc. (Ohio)
Lite ’n Foamy Lemon Blossom Hand Sanitizer
64009-331-82
64009-331-85
64009-331-88
Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020 and on 3/29/2021; FDA issued a
warning letter
on 12/15/2021
08/03/2020
Spartan Chemical Co Inc. (Ohio)
foamyiQ Lemon Blossom Hand Sanitizer
64009-202-06
Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020; FDA issued a
warning letter
on 12/15/2021
08/03/2020
Soluciones Cosmeticas SA de CV (Mexico)
Bersih Hand Sanitizer Gel Fragrance Free
75165-000-01
75165-001-01
75165-003-02
75165-004-01
75165-005-01
75165-006-01
75165-250-01
Private D Capital Group Corp., Human Choice LLC and RediBag USA Astrum LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; product voluntarily
recalled
on 7/14/2020 and updated the
recall
on 8/9/2020; FDA issued a
warning letter
on 8/4/2020
07/02/2020
Soluciones Cosmeticas SA de CV (Mexico)
Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer
75165-600-01
Astrum LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/4/2020
07/02/2020
Soluciones Cosmeticas SA de CV (Mexico)
Purity Advanced Hand Sanitizer
75165-008-01
Human Choice LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/4/2020
07/02/2020
Soluciones Cosmeticas SA de CV (Mexico)
Hand Sanitizer Gel Alcohol 70%
79095-000-01
79095-001-01
79095-002-01
79095-003-01
79095-004-01
79095-005-01
79095-006-01
Wet Look Janitorial and Gardening Corp.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/4/2020
07/10/2020
Southwest Iowa Renewable Energy
(Iowa)
SIREtizer Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
74560-001-01
74560-001-02
74560-001-03
74560-001-04
74560-001-05
Southwest Iowa Renewable Energy
FDA tested product; contains unacceptable levels of acetaldehyde and acetal;  Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 09/27/2022; product voluntarily recalled on 9/27/2022.
11/23/2022
Team Bg and Associates L.M.A., Inc.
(Louisiana)
First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%
76952-946-32
Team Bg and Associates L.M.A., Inc.
(Louisiana)
FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants.
11/23/2022
Tropicosmeticos SA de CV (Mexico)
Britz Hand Sanitizer Ethyl Alcohol 70%
76676-402-01
76676-402-02
76676-402-14
Soflo Urban Team LLC
FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Parabola Hand Sanitizer
76676-402-03
76676-402-09
Soflo Urban Team LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Urbane Bath and Body Hand Sanitizer
76676-402-04
Liberty International Distributors
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Cleaner Hand Sanitizer Rinse Free 70%
76676-402-07
76676-402-08
Liberty International Distributors
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Handzer Hand Sanitizer Rinse Free
76676-402-10
76676-402-11
Liberty International Distributors
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Kleanz Antibacterial Hand Sanitizer Advanced
76676-402-05
76676-402-06
76676-402-12
76676-402-13
Up in the Lab
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Be Safe Hand Sanitizer (labeled with “Model: BF-HGXXXX-09” where XXXX changes based on packaging size)
76676-402-16
76676-402-17
76676-402-18
76676-402-19
BeSafe Industries LLC
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA has no evidence of U.S. distribution of Be Safe Hand Sanitizer manufactured by Tropicosmeticos; FDA issued a
warning letter
on 8/10/2021
07/02/2020
Tropicosmeticos SA de CV (Mexico)
Wave Hand Sanitizer Gel
76676-402-20
C&A Marketing Inc.
Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/10/2020; FDA issued a
warning letter
on 8/10/2021
07/02/2020
True Chemical Solutions, LLC (Texas)
Hand Sanitizer B,
Hand Sanitizer C,
Hand Sanitizer E,
Hand Sanitizer G
77991-000-00
77991-001-00
77991-002-00
77991-003-00
True Chemical Solutions, LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/29/2021.
11/10/2021
Unknown
artnaturals
Scent Free Hand Sanitizer Natural Elements + Cleansing Formula
8 fl oz (236ml)
Unable to determine
Virgin Scents dba artnaturals (Gardena, CA)
FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily
recalled
on 10/26/2021; scope of overall contamination still under investigation; FDA issued a
warning letter
on 08/17/2022 and a
warning letter
on 09/01/2022.
10/04/2021
Unknown
“hand sanitizer”
Not Listed
CES LLC. (Nevada)
Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as “hand sanitizer” and “Distributed by: CES LCC 7322 S. Rainbow Blvd. Suite #166 Las Vegas, NV 89139" FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product
09/29/2021
Unknown
“hand sanitizer”
Not Listed
Chambers & Owen, Inc.
Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as “hand sanitizer” and “Distributed by: CES LCC 7322 S. Rainbow Blvd. Suite #166 Las Vegas, NV 89139"; FDA recommended the company recall on 11/3/2021; product voluntarily recalled on 11/4/2021
11/10/2021
Unknown
Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer
Not Listed
SBL Brands LLC dba Global Sanitizers LLC (Nevada)
FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily
recalled
on 5/12/2021;
recall expanded
on 5/20/2021; FDA issued a
warning letter
on 11/08/2021
12/30/2020
Unknown
Medically Minded Hand Sanitizer Gel Anitmicrobial Formula
76619-110-01
76619-110-03
76619-110-04
76619-110-05
76619-110-06
76619-110-07
76619-110-08
76619-110-09
76619-120-02
SBL Brands LLC dba Global Sanitizers LLC (Nevada)
Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily
recalled
on 5/12/2021;
recall expanded
on 5/20/2021; FDA issued a
warning letter
on 11/08/2021
12/30/2020
Unknown
Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer
60717-803-04
SBL Brands LLC dba Global Sanitizers LLC (Nevada)
Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily
recalled
on 5/12/2021;
recall expanded
on 5/20/2021; FDA issued a
warning letter
on 11/08/2021
12/30/2020
Volu-Sol Inc. (Utah)
Volu-Sol Handrub Sanitizing Solution
74401-800-16
74401-800-32
Volu-Sol
Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020
08/11/2020
Welburn Global Sociedad Anonima (Guatemala)
Happy Hands Hand Sanitizer
77991-004-01
77991-004-02
77991-004-03
77991-004-04
77991-004-05
77991-004-06
True Chemical Solutions, LLC (Texas)
Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. FDA issued a
warning letter
on 09/29/2021.
11/10/2021
Yara Elena de La Garza Perez Nieto (Mexico)
DAESI Hand Sanitizer
77268-001-01
Yara Elena de La Garza Perez Nieto
FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to
import alert
to help stop their products from entering the U.S. on 7/17/2020; ; FDA issued a
warning letter
on 2/22/2021
07/10/2020
Yangzhou Olande Cosmetic Co. Ltd (China)
Leafree Instant Hand Sanitizer
75717-001-01
CorgioMed LLC
Product labeled to be “edible alcohol”; added manufacturer to
import alert
to help stop their products from entering the U.S. on 8/11/2020; FDA recommended a recall to the distributor on 9/1/2020; product voluntarily recalled by
CorgioMed LLC
on 9/3/2020
08/11/2020
Historical References:
10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers
[10/12/2021]
Go to
FDA in Brief
10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers
[10/28/2021]
FDA is alerting health care professionals and consumers of artnaturals voluntary
recall
of limited batches of 8 oz bottles of Scent Free Hand Sanitizer.
[10/4/2021]
FDA has tested certain artnaturals scent free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248” and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to the
list
of hand sanitizers consumers should not use.
To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers.
Benzene may cause certain types of cancer in humans. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. Acetal can irritate the upper respiratory tract, eyes, and skin. While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal.
Consumers who have products on this
list of hand sanitizers
should immediately stop using the product and dispose of it, ideally in a
hazardous waste container
. Do not pour these products down the drain or flush them. Contact your
local waste management and recycling center
for more information on hazardous waste disposal.
FDA reminds
consumers
to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention
(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s
MedWatch Adverse Event Reporting
program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report
online
; or
Download and complete the
form
, then submit it via fax at 1-800-FDA-0178.
3/25/2021: UPDATE - FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination
[3/25/2021]
FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Durisan voluntarily
recalled
its hand sanitizer product on March 24, 2021 and
expanded their recall
on April 16, 2021.​
Durisan tested its hand sanitizer and found microbial contamination including high levels of
Burkholderia cepacia complex
and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. Individuals with compromised immune systems are at increased risk. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization.
The agency has updated its
do-not-use list of hand sanitizers
to include Durisan’s contaminated hand sanitizers.
Durisan’s hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Consumers who have products on the
list of hand sanitizers
with potential contamination should immediately stop using the product and dispose of it, ideally in a
hazardous waste container
. Do not pour these products down the drain or flush them. Contact your
local waste management and recycling center
for more information on hazardous waste disposal.
FDA reminds
consumers
to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention
(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA is not aware of any adverse events related to Durisan’s hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s
MedWatch Adverse Event Reporting
program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report
online
; or
Download and complete the
form
, then submit it via fax at
1-800-FDA-0178
1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
Go to
FDA Press Release
1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency
[1/19/2021]
Today, FDA issued a
guidance
outlining the agency’s policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDA’s temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic.
However, consistent with FDA’s temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source.
The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. Ethanol used to manufacturer hand sanitizer products under FDA’s temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies.
The test method for methanol described in the USP
Alcohol
Monograph can also be used to test for methanol contamination in isopropyl alcohol. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol.
The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers.
8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
Go to
FDA Press Release
8/24/2020: UPDATE – FDA provides testing method to assess the quality of hand sanitizer products for impurities
[8/24/2020]
FDA is providing a
laboratory testing method
to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDA’s temporary guidances.
Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. USP’s revision bulletin for
alcohol
and
dehydrated alcohol
monographs outlines this testing requirement, official as of September 1, 2020, which FDA
requested
to protect health care providers and consumers from using dangerous hand sanitizer products.
The agency’s investigation of contaminated hand sanitizers is ongoing.
8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination
[8/12/2020]
FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at
www.fda.gov/unsafehandsanitizers
to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use.
Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported.
Consumers who have products on the
list of hand sanitizers
with potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in a
hazardous waste container
. Do not pour these products down the drain or flush them. Contact your
local waste management and recycling center
for more information on hazardous waste disposal.
The agency continues to add certain hand sanitizers to the
import alert
to stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law.
FDA reminds
consumers
to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention
(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s
MedWatch Adverse Event Reporting
program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report
online
; or
Download and complete the
form
, then submit it via fax at 1-800-FDA-0178
8/7/2020:  UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers
8/7/2020
] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDA’s temporary policies to help ensure that harmful levels of methanol are not present in these products. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination.
FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP).
Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohol’s source.
The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities.
The agency also included an additional denaturant formula in the temporary guidances. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. Consumer and health care professional safety is a top priority for FDA, and an important part of FDA’s mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply.
For questions, contact FDA:
COVID-19-Hand-Sanitizers@fda.hhs.gov
7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products
[7/31/2020]
FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The agency urges consumers not to use these subpotent products and has expanded its
list
to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with
methanol
The agency continues to add certain hand sanitizers to
import alert
to stop these products from legally entering the U.S. market.
FDA reminds
consumers
to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention
(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19.
FDA encourages health ce professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s
MedWatch Adverse Event Reporting
program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report
online
; or
Download and complete the
form
, then submit it via fax at 1-800-FDA-0178.
7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
Go to
FDA Press Release
7/2/2020: UPDATE - FDA warns consumers of risk of methanol contamination in certain hand sanitizers
[7-2-2020]
FDA is warning consumers and health care providers that the agency has seen a sharp increase in
hand sanitizer products
that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.
The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.
Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.
Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.
FDA reminds
consumers
to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the
Centers for Disease Control and Prevention
(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:
The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products.
Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
Products labeled with harmful or poisonous ingredients, such as methanol.
FDA is aware of reports of adverse events associated with hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s
MedWatch Adverse Event Reporting
program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report
online
; or
Download and complete the
form
, then submit it via fax at
1-800-FDA-0178
7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol
Go to
FDA Press Release
6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
Go to
FDA Drug Alert
Content current as of:
04/02/2026
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