Drug Recall Checklist

Summary

This checklist outlines key considerations specific to recalls of drug products regulated by the U.S. Food and Drug Administration (FDA). Drug recalls are voluntary market actions taken by drug manufacturers to remove potentially defective drug product from the market. Most recalls are conducted in close coordination with FDA but if FDA is not satisfied with a company's voluntary recall efforts, it may take additional steps, including initiating a judicial enforcement action (i.e., seizure).