[ 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.

1,235 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0427-2026	Lack of Assurance of Sterility	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-0424-2026	Lack of Assurance of Sterility	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	Fresenius Kabi USA, LLCD-0431-2026	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	Fagron Compounding ServicesD-0441-2026	Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port	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	Fresenius Kabi USA, LLCD-0433-2026	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	GE Healthcare Ireland LimitedD-0448-2026	Presence of particulate matter	Environmental Monitoring
2026-04-15	Class I	AYCO FARMS INCH-0668-2026	Potential Salmonella Contamination	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0436-2026	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	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	Connecticut Crab Company LLCH-0656-2026	May be temperature abused, which may result in growth of Clostridium botulinum	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0416-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0413-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0410-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0415-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-08	Class II	Medline Industries, LPZ-1693-2026	There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0414-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-08	Class II	Oxoid Australia Pty LimitedZ-1766-2026	Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.	Environmental Monitoring
2026-04-08	Class II	JFE FRANCHISING INCH-0639-2026	Foreign Object (Glass)	Environmental Monitoring
2026-04-08	Class II	K.C. Pharmaceuticals, IncD-0411-2026	Lack of Assurance of Sterility	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.