FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction are published in Title 21 of the Code of Federal Regulations, Part 7. These guidelines make clear that FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.
