[ 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.

839 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0436-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fagron Compounding ServicesD-0442-2026	Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0430-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0425-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0437-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	GE Healthcare Ireland LimitedD-0448-2026	Presence of particulate matter	Environmental Monitoring
2026-04-15	Class II	Cipla USA, Inc.D-0422-2026	Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.	Environmental Monitoring
2026-04-15	Class II	Fagron Compounding ServicesD-0439-2026	Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0435-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0432-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0472-2026	CGMP Deviations: use of an unapproved raw material	Documentation & Change Control
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0473-2026	CGMP Deviations: use of an unapproved raw material	Documentation & Change Control
2026-04-15	Class II	Cipla USA, Inc.D-0423-2026	Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.	Environmental Monitoring
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0474-2026	CGMP Deviations: use of an unapproved raw material	Documentation & Change Control
2026-04-15	Class II	Fagron Compounding ServicesD-0440-2026	Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0428-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0446-2026	Superpotent and Subpotent	Validation & Qualification
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0426-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0424-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0427-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fagron Compounding ServicesD-0438-2026	Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port	Environmental Monitoring
2026-04-15	Class II	GE Healthcare Ireland LimitedD-0447-2026	Presence of particulate matter	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0433-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0431-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Viatris, Inc.D-0444-2026	Failed Dissolution Specifications	Validation & Qualification

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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.