[ 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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3,465 matching recalls
DateClassFirmReasonQuality domain
2026-05-27Class ISolina U.S. HoldingH-0825-2026potential to be contaminated with SalmonellaEnvironmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0802-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IJOHN B SANFILIPPO & SONS INCH-0834-2026potential presence of SalmonellaEnvironmental Monitoring
2026-05-27Class IIISagent PharmaceuticalsD-0539-2026Failed Impurities/Degradation SpecificationsValidation & Qualification
2026-05-27Class IIZydus Pharmaceuticals (USA) IncD-0545-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-27Class IGhirardelli Chocolate CompanyH-0840-2026Potential contamination with Salmonella.Environmental Monitoring
2026-05-27Class IIIAmerisource Health Services LLCD-0537-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
2026-05-27Class IILupin Pharmaceuticals Inc.D-0541-2026Presence of particulate matter: a white thread-like structure in the cartridgeEnvironmental Monitoring
2026-05-27Class IWisconsin Pharmacal CompanyD-0553-2026Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.Environmental Monitoring
2026-05-27Class IIIGolden State Medical Supply Inc.D-0535-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
2026-05-27Class IIZydus Pharmaceuticals (USA) IncD-0544-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-27Class IISafecor Health, LLCD-0538-2026Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.Documentation & Change Control
2026-05-27Class IISafecor Health, LLCD-0549-2026Presence of a Foreign Substance; black particles observed in liquid—
2026-05-27Class IIWellnov Supplements LLCH-0804-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IIHaleon US Holdings LLCD-0542-2026Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.Documentation & Change Control
2026-05-27Class IIILannett Company Inc.D-0533-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
2026-05-27Class IIANI Pharmaceuticals, Inc.D-0543-2026Defective Container; packets were found to be either empty or partially full.—
2026-05-27Class IILlorens Pharmaceuticals International Division, Inc.H-0809-2026Foreign object: black particulate matterEnvironmental Monitoring
2026-05-27Class IIIAmerisource Health Services LLCD-0536-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
2026-05-27Class IIUCB Biosciences Inc.D-0546-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-05-27Class IIIntegraDose Compounding Services LLCD-0548-2026Subpotent DrugValidation & Qualification
2026-05-27Class IILIQUID BLENZ CORPH-0787-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0794-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0797-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IIIGolden State Medical Supply Inc.D-0534-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.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.