[ 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.

1,232 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-02-18	Class II	Fresenius Kabi Compounding, LLCD-0336-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0323-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0321-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0478-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0472-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0450-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0451-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class II	WinCo Foods LLCH-0449-2026	Product may contain foreign material (metal fragments).	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0469-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0467-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0477-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Khee Trading, Inc.H-0482-2026	Imported oysters potentially contaminated with Norovirus	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0455-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0480-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0468-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0456-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0452-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0475-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0454-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0471-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class I	Tradin Organics USA LLCH-0460-2026	Potential contamination with Salmonella.	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0479-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0474-2026	potential Clostridium botulinum contamination	Environmental Monitoring
2026-02-11	Class I	Everpress JuiceH-0453-2026	Under-processed product may contain pathogenic bacteria that could harm to humans.	Environmental Monitoring
2026-02-11	Class II	Diva Fam IncH-0470-2026	potential Clostridium botulinum contamination	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.