[ 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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839 matching recalls
DateClassFirmReasonQuality domain
2026-06-03Class IIIAVEVA Drug Delivery Systems, Inc.D-0550-2026Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.Validation & Qualification
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 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 IIZydus Pharmaceuticals (USA) IncD-0544-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-27Class IIISagent PharmaceuticalsD-0539-2026Failed Impurities/Degradation SpecificationsValidation & Qualification
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
2026-05-27Class IILupin Pharmaceuticals Inc.D-0541-2026Presence of particulate matter: a white thread-like structure in the cartridgeEnvironmental Monitoring
2026-05-27Class IIUCB Biosciences Inc.D-0546-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-05-27Class IIANI Pharmaceuticals, Inc.D-0543-2026Defective Container; packets were found to be either empty or partially full.—
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 IIIAmerisource Health Services LLCD-0537-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental 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 IIIntegraDose Compounding Services LLCD-0548-2026Subpotent DrugValidation & Qualification
2026-05-27Class IISafecor Health, LLCD-0549-2026Presence of a Foreign Substance; black particles observed in liquid—
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 IIZydus Pharmaceuticals (USA) IncD-0545-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-20Class IIOasis Medical, Inc.D-0525-2026Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.Environmental Monitoring
2026-05-20Class IIAscend Laboratories, LLCD-0547-2026Failed Dissolution SpecificationsValidation & Qualification
2026-05-20Class IIENDO USA, Inc.D-0527-2026Crystallization; identified as Buprenorphine free base—
2026-05-13Class IIBreckenridge Pharmaceutical, Inc.D-0522-2026CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitValidation & Qualification
2026-05-13Class IIIUnichem Pharmaceuticals USA Inc.D-0511-2026Subpotent drugValidation & Qualification
2026-05-13Class IIAjanta Pharma Ltd.D-0516-2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Validation & Qualification
2026-05-13Class IIJB Chemicals and Pharmaceuticals LtdD-0520-2026Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities TestValidation & Qualification
2026-05-13Class IICareFusion 213, LLCD-0518-2026Lack of assurance of Sterility: potential product contaminationEnvironmental 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.