FDA Drug Recalls

Search active drug recalls and enforcement actions by manufacturer or product. Classification (Class I–III), reason, distribution scope, and FDA report date.

Examples: Pfizer · metformin · Teva Pharmaceuticals · amoxicillin

Class

Why this exists

Drug recalls are the public-record signal of quality-system failure. For healthcare investors, MSP customers in pharma, or anyone evaluating a CMO/CDMO, a recent Class I against a recipe or a manufacturer is the conversation, not the deck. The FDA exposes the full enforcement record via the openFDA API.

Frequently asked questions

What does FDA Drug Recalls return?

Active and historical drug recalls from FDA's enforcement database — by manufacturer, brand name, or active ingredient. Returns recall classification (Class I most serious, II, III), reason for recall, distribution scope, and FDA report date.

What's the data source?

openFDA, the FDA's public data API. Sources from the FDA's Enforcement Reports system, updated weekly with new recalls. Coverage starts in 2012 with full data.

Healthcare-diligence use case?

Pharma and biotech M&A target-company recall history, vendor risk for hospital purchasing, journalism on drug-safety patterns, and investor pre-call diligence on any healthcare position.