Certain lots of hand sanitizers are being recalled from the market because they do not meet Health Canada requirements.
UPDATE: More hand sanitizers added to the recall list (in green below)
Recalled hand sanitizers are listed below. See the link at the bottom for full information regarding the lot numbers of affected products.
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.
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:
- the list of Health Canada-authorized hand sanitizers ; and
- the list of hand sanitizers authorized or registered in other jurisdictions that may not display a Natural Product Number (NPN) or Drug Identification Number (DIN) but have been accepted for use in Canada during the COVID-19 pandemic
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).
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 and Reason(s) for Recall
Aerochem Liquid Hand Cleaner 70% Alcohol
- Not authorized for sale in Canada
- contains unacceptable ingredient, ethyl acetate
Bio-Odeur
- Not authorized for sale in Canada
Defenz
- Not properly labelled (Missing correct NPN, lot number, directions for use, and risk statements)
Embassy Hand Sanitizer
- Contains undeclared impurity, acetaldehyde, at elevated levels; not properly labelled (including missing risk statements and information for vulnerable population in French)
Gigi's Goodbye Germs Hand Sanitizer (NPN 80101167)
- Not authorized for sale in Canada
- insufficient quality oversight of the product
- sold without proper testing
- contains undeclared impurity, acetaldehyde, at elevated levels
Hand San Gel
- Product not authorized to contain technical-grade ethanol
JP Wiser's Distillery
- Contains unacceptable ingredient, ethyl acetate
KeraSpa
- Contains unacceptable ingredient, ethyl acetate
- Contains undeclared impurity, acetaldehyde, at elevated levels
- Contains undeclared impurity, acetaldehyde, at elevated levels
- Not authorized for sale in Canada
- Contains unacceptable ingredient, ethyl acetate
Prevent+
- Potential bacterial contamination with Burkholderia stabilis
Prevent+ Foam Sanitizer
- Potential bacterial contamination with Burkholderia stabilis
Prevent+ Rubbing Alcohol, 70%
- Potential bacterial contamination with Burkholderia stabilis
Puricia
- Contains undeclared impurities, benzene and methanol, at elevated levels
- Not authorized for sale in Canada
- contains unacceptable ingredient, methanol
- Not authorized for sale in Canada
- missing risk statements
- product not authorized to contain technical-grade ethanol
- Missing risk statements
- product not authorized to contain technical-grade ethanol
- Missing risk statements
- product not authorized to contain technical-grade ethanol
- Contains undeclared impurity, benzene, at elevated levels
- Contains unacceptable ingredient, ethyl acetate
For more information, please review the full Recall & Safety Alert here. Health Canada will update this list if there are other affected products. Canadians are encouraged to consult the list regularly for updates.
