[ 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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409 matching recalls
DateClassFirmReasonQuality domain
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0271-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0264-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0263-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0267-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0265-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0266-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0272-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIEncon Safety Products CoD-0260-2026cGMP deviations.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0282-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0261-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0278-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0274-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0286-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0287-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0269-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0281-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0284-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0285-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0283-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0280-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0270-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0268-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0277-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0279-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
2026-01-21Class IIGOLD STAR DISTRIBUTION INCD-0273-2026CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.Risk Management & CAPA
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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.