Question Period Note: Recalls (General)

News outlets regularly feature product recalls in Canada, including for products regulated by Health Canada.

• This government’s top priority is the health and safety of Canadians.
• Health and consumer products sold in Canada must comply with federal laws and regulations. If a risk is identified, we expect industry to address issues swiftly, including through product recalls when appropriate.
• Health Canada closely monitors the marketplace and will not hesitate to take action to help protect Canadians from unsafe products.
• The department’s priority is to ensure that people in Canada have the information they need to make informed decisions about their health. Health Canada regularly publishes recalls, advisories, and safety alerts to keep Canadian safe.
IF PRESSED ON DRUG, MEDICAL DEVICE OR NATURAL HEALTH PRODUCT RECALLS
• Health Canada may become aware of potential health product issues through company notifications, consumer or industry complaints, or through its own proactive compliance monitoring activities.
• Depending on the issue, a recall may be necessary. If a regulated party fails to effectively recall a health product, Health Canada will not hesitate to take further enforcement action to protect Canadians and keep them informed.
• Should the department have reason to believe that a health product presents a serious or imminent risk to health, it also has the power to order a recall if a company does not take action in a timely manner.
IF PRESSED ON CONSUMER PRODUCT RECALLS
• Regulated parties carry out recalls to remove consumer products from the Canadian market that may pose a risk, as well as to minimize the risk to consumers by advising the public of what to do if they have a product that has been recalled.
• Health Canada may order a recall of a consumer product if it believes that the product is a danger to human health or safety.
• The department takes steps to ensure consumers are made aware of recalls and the actions they should take through postings on its website and social media.

Health Canada is responsible for regulating the safety and quality of health and consumer products in Canada. This includes informing and protecting Canadians from health and safety risks associated with these products after they are made available to consumers. Persons manufacturing, importing, advertising or selling health or consumer products in Canada must ensure that their products comply with federal laws and regulations.
News outlets regularly feature articles about product recalls posted on the Recalls and safety alerts website. A recall is meant to address an issue that presents significant risk to the health and safety of consumers.
Industry may carry out all recalls in a voluntary manner when they become aware of potential health and safety risks of a product. This voluntary approach helps industry to provide the people in Canada with quick and reliable information on how they can help protect themselves from dangerous products. Health Canada monitors recalls to ensure they effectively manage the identified risk. Some federal legislation also provides the Minister of Health the power to order a mandatory recall if they believe a drug, medical device, natural health product or consumer product presents a serious or imminent risk to the health and safety of consumers.
In 2014, the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) amended the Food and Drugs Act (FDA) to improve the safety and oversight of therapeutic products (i.e., drugs and medical devices) by introducing measures to, among other things, enable the Minister to order a person who sells a drug or medical device to recall the product when the Minister believes there is a serious or imminent risk of injury to health. While a manufacturer or importer is expected to voluntarily initiate a recall if their product is found to pose a risk to health, a mandatory recall order can be used by the department to remove a non-compliant product from the market. In 2023, the Government amended the FDA’s definition of therapeutic products to extend these authorities under Vanessa’s Law to natural health products, including the power to order recalls.
Additionally, the Canada Consumer Product Safety Act authorizes the Minister of Health to order a recall of a consumer product if they believe, on reasonable grounds, that the product is a danger to human health or safety. A recall order would be addressed to a person who manufactures, imports, or sells a product for commercial purposes. The Minister of Health may also order a person to take certain measures, including stopping the manufacturing or sale of a consumer product, or any other measure to address or prevent a danger to human health or safety. If a person does not comply with a recall order or an order to take corrective measures within the time specified, Health Canada may issue administrative monetary penalties carrying fines of up to $25,000 a day and can also carry out the recall or the corrective measure at the person's expense.

• Health Canada is responsible for regulating the safety and quality of health and consumer products in Canada. Persons manufacturing, importing, advertising or selling health or consumer products in Canada must ensure that their products comply with federal laws and regulations.
• Recalls are a key tool used to address issues with products that present risks to the health and safety of consumers. A recall is a corrective action taken by government or industry to address consumer health or safety issues associated with a product, and may include removing a product from distribution.
• Product recalls are most often initiated by industry to take corrective measures to address health and safety risks. Health Canada monitors recalls and may take enforcement action if industry does not comply with applicable legislation, including by issuing mandatory recalls for some products.
• Health Canada takes steps to advise the public when products are recalled, for example through the Recalls and Safety Alerts website which provides easy access to a comprehensive list of recalls, advisories, and safety alerts for health and consumer products.