Product Recalls Including Removals and Corrections

This guidance document is intended to provide guidance and recommendations to FDA-regulated industry regarding what information firms should give to the Food and Drug Administration (FDA) and how they should notify their customers about product recalls. This guidance is intended to assist those members of industry regulated by the FDA in handling most aspects of a product recall, as well as some removals and corrections which do not meet the definition of a recall under 21 CFR 7.3. The guidance includes a checklist of documentation and information that industry can provide to the FDA that will be used by FDA to evaluate, classify, monitor and audit product recalls. Various statutory provisions and regulations, described below, authorize the FDA to require recalls of certain products in particular circumstances. Additionally, subpart C of part 7 of FDA regulations (21 CFR 7.40-59) provides general guidance for the voluntary recall of products, including those recalls initiated by a firm on its own and at the FDA’s request. This guidance provides more specific recommendations and applies to voluntary and, to the extent that the guidance does not conflict with statute or regulation, mandatory recalls of all FDA-regulated products (i.e., food, including animal food; drugs, including animal drugs; medical and radiological devices and products; cosmetics; tobacco products; and biological products.)