Recall of certain hand sanitizers that may pose health risks (Part 2 – March 31, 2021 to present)

Starting date:
March 31, 2021
Posting date:
July 23, 2021
Type of communication:
Advisory
Subcategory:
Natural Health Products - Homeopathic Medicine
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-75267

Last updated:

Summary

  • Product: Hand sanitizers that may pose health risks.
  • Issue: Certain hand sanitizers are being recalled because they do not meet Health Canada’s requirements.
  • What to do: Stop using the identified product lots below. Consult your health care professional if you have used any of these products and have health concerns. Report any health product adverse events or complaints to Health Canada. See the additional information on buying health products safely in the links below.

Issue

Certain lots of hand sanitizers are being recalled from the market because they do not meet Health Canada requirements. Reasons for recall include:

  • containing (or possibly containing) ingredients that are not permitted by Health Canada;
  • containing undeclared impurities at elevated levels;
  • improper labelling;
  • missing risk statements;
  • being unauthorized for sale in Canada;
  • being sold without proper product testing;
  • being counterfeit; or
  • having defective or faulty packaging.

Recalled hand sanitizers are listed in the table below. The table lists the reason for recall and includes information regarding the lot numbers of affected products.

Health Canada will update this list if there are other affected products. Canadians are encouraged to consult the list regularly for updates.

What you should do

  • Stop using the products identified in the table.
    • Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
    • Return the product to your local pharmacy for proper disposal
  • Contact the company if you would like more information about the recall
  • Consult your health care professional if you have used these products and have health concerns

To help limit the spread of COVID-19, wash your hands often with soap and water for at least 20 seconds.

If soap and water are not available, use alcohol-based hand sanitizers that have been authorized for sale in Canada. Consult these resources for more information:

Report any health product adverse events or complaints to Health Canada.

Background

The COVID-19 outbreak has created a high demand for hand sanitizers. To increase the supply, Health Canada has taken several measures, including permitting the temporary use of technical-grade ethanol in alcohol-based hand sanitizers.

Manufacturers wishing to use technical-grade ethanol must choose from a list of Health Canada-authorized suppliers. They must receive a No Objection Letter from us before they can manufacture or distribute the product.

Technical-grade ethanol contains more impurities than pharmaceutical- and food-grade ethanol. Therefore, manufacturers must include the following risk statements on their product labels if the ethanol impurities exceed a certain level:

  • Under Medicinal Ingredients: "Ethanol XX% (technical-grade)"
  • Under Directions: "Adults only"
  • Under Warnings: "Do not use on broken or damaged skin," "Not recommended if you are pregnant or breastfeeding" and "Do not inhale"
  • Include a statement for consumers: "Report any incident to Health Canada"
  • Under Questions: "Call 1-866-234-2345 to report any adverse reaction"

Hand sanitizers that contain unacceptable grades of ethanol, undeclared impurities at elevated levels, or unauthorized denaturants have not been reviewed for safety or efficacy. Denaturants are added to ethanol to make it taste bad, to discourage the unintentional ingestion of hand sanitizers, especially by children.

Two unauthorized denaturants have been found in hand sanitizers sold in Canada:

  • Ethyl acetate: Frequent use of hand sanitizer containing ethyl acetate may cause dry skin, leading to irritation or cracking
  • Methanol: Frequent use of hand sanitizer containing methanol may cause dermatitis, eye irritation, upper respiratory system irritation and headaches

An unauthorized medicinal ingredient has been found in hand sanitizers sold in Canada:

  • 1-Propanol: Frequent use of hand sanitizer containing 1-propanol may cause eye, nose and throat irritation, as well as dry cracking skin, drowsiness and headache

Two undeclared impurities at elevated levels have been found in hand sanitizers sold in Canada:

  • Acetaldehyde: Hand sanitizer containing elevated levels of the impurity acetaldehyde may increase the risk of cancer. This risk is assumed to increase with use (e.g., frequent applications over a long period of time)
  • Benzene: Hand sanitizer containing elevated levels of the impurity benzene may increase the risk of cancer. In addition, exposure (e.g. through inhalation or applying to the skin) to elevated levels of benzene may cause drowsiness, dizziness, rapid or irregular heartbeat, and headaches. These risks are assumed to increase with use (e.g., frequent applications over a long period of time).

All health products, including hand sanitizers, must be tested before they can be sold in Canada. Testing is done to ensure the product meets Health Canada's required safety, quality and efficacy standards.

Counterfeit products may contain ingredients not listed on the label, dangerous additives or other contaminants. In addition, they may not contain the active ingredients Canadians would expect them to contain. Since counterfeit products are unauthorized and made with an unknown formulation, they may not be effective at killing bacteria and viruses, and may pose serious risks to health.

Affected products

Certain hand sanitizers are being recalled because they either contain ingredients that are not permitted by Health Canada or are not properly labelled and are missing important information.
See table Part 1 and Part 2 below. Links to previous tables with affected products are also available below.
 

Product description

Affected products
Product Reason for recall Recalling company NPN or DIN Affected lot number(s) Expiry date Date added
Absolute Hand Sanitizer; Gely Contains undeclared impurity, benzene, at elevated levels; not properly labelled (including missing information for vulnerable population) Canada Direct Imports 80099745 20200601 June 2022 2021-07-12
Aerochem Liquid Hand Cleaner 70% Alcohol Not authorized for sale in Canada; contains unacceptable ingredient, ethyl acetate Walter Surface Technologies Inc. Unlicensed (no NPN or DIN on the label)
  • 200342480
  • 200342485
  • 200342486
  • 200342487
  • 200342488
  • 200342489
  • 200342491
  • 200342492
  • 200342497
  • 200442587
Not printed on the label 2021-04-07
Avalon Laboratories - Ethanol Hand Sanitizer 80%; Securol Hand Sanitizer Contains undeclared impurity, acetaldehyde, at elevated levels Avalon Laboratories 80101239 E062220B June 2022 2021-07-12
Bio-Odeur Not authorized for sale in Canada Bio-Expert Products Inc. Unlicensed (no NPN or DIN on the label) All All 2021-05-10
Defenz Not properly labelled (Missing correct NPN, lot number, directions for use, and risk statements) Shiny Star Canada Ltd.

80100296 appears on the label, which is the wrong NPN.

80100294 is the correct NPN.

Not printed on the label May 2022 2021-06-22
Gigi's Goodbye Germs Hand Sanitizer Not authorized for sale in Canada; insufficient quality oversight of the product Simply At Home Inc. 80101167
  • BB/MA 02/JN/2025
  • BB/MA 03/JN/2025
June 2025 2021-04-07
Gigi's Goodbye Germs Hand Sanitizer Not authorized for sale in Canada; sold without proper testing; contains undeclared impurity, acetaldehyde, at elevated levels Simply At Home Inc. 80099956 All All 2021-03-31
Hand Sanitizer Contains undeclared impurity, acetaldehyde, at elevated levels; not properly labelled (including missing risk statements and information for vulnerable population) Latitude 55 Distilling Co. 80099859 All All 2021-07-12
iMed Hand Sanitizer; Yinba Contains undeclared impurity, benzene, at elevated levels; not properly labelled (including missing all risk statements in French) MTI-Mobiltech International Inc. 80098244 YB5019 - MFG-21032020 March 2022 2021-07-12
JP Wiser's Distillery Contains unacceptable ingredient, ethyl acetate Hiram Walker & Sons Limited 80098173

200324-133735

Not printed on the label 2021-04-07
KeraSpa Contains unacceptable ingredient, ethyl acetate Adbo Distribution 80076597 appears on the label, which is the wrong NPN
  • 100G01
  • 101G01
  • 104G01
  • 111G01
  • 112G01
April 2023 2021-05-03
Luxe Health Hand Sanitizer Gel (Ethyl Alcohol 74%) Contains undeclared impurity, benzene, at elevated levels Luxe Decor Sales Ltd. 80098844 20200531 May 2022 2021-07-02
MediCare Foaming Hand Sanitizer May contain undeclared impurity, acetaldehyde, at elevated levels; Not properly labelled (missing information for vulnerable population) Dollarama L.P. 80100289 45051156114 45051156115 45051156116 October 2023 November 2023 December 2023 2021-07-23
Natural Concepts Sanitizing Gel Contains undeclared impurity, acetaldehyde, at elevated levels Apollo Health and Beauty Care Inc. 80097861
  • A198667
  • A198673
  • A198804
April 2022 2021-05-28
Peak Processing Solutions - Ethanol sanitizer 80% Contains undeclared impurity, acetaldehyde, at elevated levels 2682130 Ontario Limited (o/a Peak Processing Solutions) 80098093 PPS00000001 Not printed on the label 2021-06-22
Natural Concepts Sanitizing Gel Contains undeclared impurity, acetaldehyde, at elevated levels Apollo Health and Beauty Care Inc. 80097861
  • A198801
  • A198803
  • A198823
  • A198824
  • A198825
  • A198983
  • A199077
  • A199078
  • A199169
  • A199170
  • A199181
  • A199249
May 2022 2021-05-28
Preference Pre-Quat Sanitizer Not authorized for sale in Canada Les Produits Sanitaire Accord Inc. Unlicensed (no NPN or DIN on the label) All Not printed on the label 2021-03-31
Premium Hand Gel Sanitizer Contains unacceptable ingredient, ethyl acetate Ambassador Oil and Gas (current product license holder is Sunbee Environmental Solutions) 80098388
  • 0420-01
  • 0420-02
  • 0420-03
April 2021 2021-04-07
Premium Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Ambassador Oil and Gas (current product license holder is Sunbee Environmental Solutions) 80098358
  • 0420-04
  • 0420-05
April 2021 2021-04-07
Pur-Vie Contains undeclared impurity, benzene, at elevated levels Literies Universelles Paga Inc. 80101600 11/2020 November 2022 2021-07-23
Puricia Contains undeclared impurities, benzene and methanol, at elevated levels Pharmaberg Inc. 80100723 PABS0820 July 2022 2021-06-22
Safe-Guard Product Canada Hand Sanitizer Not authorized for sale in Canada; contains unacceptable ingredient, methanol St. Joseph Communications Unlicensed (no NPN or DIN on the label) 2020/05/11 May 2023 2021-04-07
Salon Solution Waterless Hand Wash Not authorized for sale in Canada; missing risk statements; product not authorized to contain technical-grade ethanol CBON Cosmetic Brands of North America Inc. Unlicensed (no NPN or DIN on the label) Not printed on the label Not printed on the label 2021-04-19
SunnaPure Hand Sanitizer Spray Missing risk statements; product not authorized to contain technical-grade ethanol Cosmetics by Katakami Inc. 80099057
  • 0620-1
  • 0620-2
  • 0620-3
  • 0620-4
June 2022 2021-06-22
T-1000 Missing risk statements; product not authorized to contain technical-grade ethanol One-Bottle (9353-8957 Québec Inc.) 80103120 All. Not printed on the label. Not printed on the label 2021-05-10
TerraPure Hand Sanitizer Contains undeclared impurity, benzene, at elevated levels TerraPure Sanitizer Inc. 80103052 201116-03 November 2023 2021-06-22
Umbrell (60 mL format) Contains unacceptable ingredient, ethyl acetate Affinite Gestion de Production 80076597
  • 099G01
  • 100G01
April 2023 2021-05-03
Wayward Distillery WHO Formula Hand Rub Contains undeclared impurity, acetaldehyde, at elevated levels; not properly labelled (including missing all risk statements in French and information for vulnerable population) Wayward Distillery 80098231 # 45 October 2022 2021-07-12


Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca

What Health Canada is doing

We have directed companies to stop selling these products.

We are monitoring the situation. If we identify other products that do not meet Health Canada requirements, we will take appropriate action and inform Canadians by updating this list.