Recall of certain hand sanitizers that contain technical-grade ethanol

Last updated: 2020-06-24

• 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.

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.

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.

Affected products

Certain hand sanitizers made with technical-grade ethanol

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

• 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.