[ FDA ENFORCEMENT INTELLIGENCE ]

Learn from the record. Every FDA recall is a quality signal.

Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.

1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN

Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.

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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-06-17Class ISUN PHARMACEUTICAL INDUSTRIES INCD-0580-2026Presence of Particulate matter: Particulate matter identified as glass.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2336-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IHaleon US Holdings LLCD-0595-2026Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2350-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2347-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class ITotal Nutrition IncH-0942-2026Product may be contaminated with Salmonella.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2349-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAVID Medical, Inc.Z-2407-2026Inadvertent distribution of sealed pouches that had not undergone validated sterilization.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2345-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2333-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIZep IncD-0586-2026Microbial contamination of sterile productsEnvironmental Monitoring
2026-06-17Class IIBoston Scientific Neuromodulation CorporationZ-2404-2026Sterile anchors my lack sterility assurance.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2338-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IBEEKEEPER'S NATURALS USA INC.D-0620-2026Microbial Contamination of Non-Sterile ProductsEnvironmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2348-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2346-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2335-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2339-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2340-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2343-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2334-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2351-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2337-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2352-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
2026-06-17Class IIAvanos Medical, Inc.Z-2342-2026Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.Environmental Monitoring
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Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.