Recall of certain hand sanitizers that contain technical-grade ethanol
- Starting date:
- June 24, 2020
- Posting date:
- July 6, 2020
- Type of communication:
- Drugs, Natural health products
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
- Product: Certain hand sanitizers made with technical-grade ethanol.
- Issue: Health Canada is advising Canadians that certain hand sanitizers containing technical-grade ethanol are being recalled from the market because they are not compliant with federal regulations and may pose a risk to health.
- What to do: Stop using these products. Consult your healthcare 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.
- What you should do
- Affected products
- Related AWRs
- Media enquiries
- Public enquiries
- What Health Canada is doing
Health Canada is advising Canadians that certain hand sanitizers containing technical-grade ethanol are being recalled from the market because they are not compliant with federal regulations and may pose a risk to health.
Given supply shortages of pharmaceutical- and food-grade ethanol, on April 15, 2020, Health Canada permitted 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 and receive a No Objection Letter from Health Canada before manufacturing or distributing 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:
- Under Medicinal Ingredients: “Ethanol XX% (technical-grade)”
- Under Directions: “Adults only”
- Under Warnings: “Do not use on broken or damaged skin,” “Do not use 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”
Health Canada is advising Canadians to stop using the products on the list below. The Department will update this list if it becomes aware of other affected products, so that Canadians can easily identify ones they may have purchased and take appropriate action. Canadians are encouraged to consult the list regularly for updates.
What you should do
- Stop using the products listed below. Please follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste. You may also return the products to your local pharmacy for proper disposal.
- 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. Use alcohol-based hand sanitizers if soap and water are not available.
- Use hand sanitizers that have been authorized for sale in Canada. Hand sanitizers that have been authorized will display either a Natural Product Number (NPN) or Drug Identification Number (DIN) on the product label. These products can be found on the list of hand sanitizers that meet Health Canada’s requirements or have been allowed to be imported under an interim measure.
- Report any health product adverse events or complaints to Health Canada.
Certain hand sanitizers made with technical-grade ethanol
Please note that the products in the following table are listed alphabetically, rather than by the date they were added.
80100505 is the correct NPN. 20-0110
|Product||Reason for recall||Recalling Company||NPN or DIN||Lot number(s)||Date Added|
|Ascencia Désinfectant pour les mains||Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements||Arclay Natural Technologies||80098625 appears on the label, which is the wrong NPN. 80100505 is the correct NPN.||EN142||July 6, 2020|
|Avery Essentials Hand Sanitizer||Missing risk statements; product not authorized to contain technical-grade ethanol||Universal Consumer Brands||80099591||20E31A||June 24, 2020|
|June 24, 2020|
Med Clean Hand
|Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements||Brands International Corporation||80021511||20100001||June 24, 2020|
|Protectenol Hand Sanitizer||Missing risk statements||Applied Lubrication Technology Inc.||80098373||
|July 6, 2020|
20-075 to 20-082
20-084 to 20-100
20-103 to 20-144
20-148 to 20-209
20-211 to 20-295
20-298 to 20-306
20-310 to 20-312
20-314 to 20-330
20-338 to 20-363
|June 24, 2020|
|Sanify Hand Sanitizer||Product not authorized to contain technical-grade ethanol; missing risk statements||Lusty Libation, Inc.||80099248||
|July 6, 2020|
|Visibly Clean Hand Sanitizer||Not authorized for sale in Canada||Brands International Corporation||None||All||June 24, 2020|
What Health Canada is doing
- Health Canada has directed companies to stop the sale of these products and is monitoring the effectiveness of the recalls.
- If Health Canada identifies additional products or manufacturers using ethanol that does not meet Health Canada requirements, the Department will take appropriate action and inform Canadians, including updating this list.
- Health Canada has also issued a recall of certain hand sanitizers containing industrial-grade ethanol.
For more information
- Natural Health Products
- Licensed Natural Health Product Database
- Hard surface disinfectants and hand sanitizers (COVID-19)
- Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products
- Technical Grade Ethanol Risk Assessment Summary Report
- Health Canada's decision on technical-grade ethanol for the manufacture of hand sanitizers: Notice to industry
- Date modified: