White Paper: FDA 101: Product Recalls — From First Alert To Effectiveness Checks

When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. In most cases, a recall results from an unintentional mistake by the company, rather than from an intentional disregard for the law.

Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.