A recall is an action taken by a company to correct or remove from the market an FDA regulated product that violates U.S. laws and regulations. Recalls may be initiated voluntarily by a company, or at the request of the FDA.
Recalls are important because they protect the public from products that may cause injury, illness or even death. More than 83,000 FDA regulated products were recalled between 2014 and 2024.
Most recalls involve removing violative FDA regulated products from the market, but there are instances where a violation can be corrected without removing the products from distribution. For example:
