The U.S. Food and Drug Administration (FDA) recently published finalized guidance on the Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, available here. This guidance falls under FDA’s Foodborne Illness Outbreak Response Improvement Plan, initiated in December 2021, and applies to voluntary recalls of all products subject to FDA jurisdiction, including human and animal food, drugs, and others. The guidance is directed at all firms in product distribution chains.
Initiation of Voluntary Recalls contains nonbinding recommendations on how firms should prepare voluntary recall processes, including recommended procedures. It also discusses steps that firms should take if there is an indication of an issue with a distributed product, how a firm should initiate a voluntary recall, and how FDA can support firms in the timely execution of voluntary recalls.