Drug Recall
The removal of a pharmaceutical product from the market due to safety concerns, quality defects, or regulatory violations. Recalls are classified by severity: Class I (serious health risk), Class II (temporary or reversible health risk), Class III (unlikely to cause adverse health effects).
Technical Context
FDA recall classification: Class I (reasonable probability that product will cause serious health consequences or death — e.g. sterility failure in an injectable peptide), Class II (may cause temporary or medically reversible adverse health effects — e.g. mislabelling, incorrect concentration), Class III (not likely to cause adverse health effects — e.g. cosmetic defect in labelling). Recalls may be: firm-initiated (manufacturer voluntarily recalls after detecting a problem), FDA-requested (FDA identifies problem and requests recall), or FDA-mandated (rare — FDA has limited mandatory recall authority for devices but broader authority under the Food Safety Modernization Act for food). For compounded peptide products, recalls have been issued for: sterility failures, endotoxin contamination, superpotency/subpotency, and use of unapproved bulk drug substances. Recall notifications are published on the FDA website and distributed through recall alerts.