[ 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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1,232 matching recalls
DateClassFirmReasonQuality domain
2026-02-11Class IIVENZU TRADERS LLCH-0466-2026Potential contamination with heavy metal (lead).Environmental Monitoring
2026-02-11Class IIDiva Fam IncH-0476-2026potential Clostridium botulinum contaminationEnvironmental Monitoring
2026-02-11Class IIDiva Fam IncH-0473-2026potential Clostridium botulinum contaminationEnvironmental Monitoring
2026-02-04Class ISUPERFOODS, INC.H-0434-2026Products may be contaminated with Salmonella TyphimuriumEnvironmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0425-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0424-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0430-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0427-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIBaxter Healthcare CorporationD-0296-2026Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solutionEnvironmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0429-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIQUTEN RESEARCH INSTITIUTE LLCH-0418-2026Mold contamination detected for raw material lots that were produced in July and used in finished goods.Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0426-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class ISUPERFOODS, INC.H-0433-2026Products may be contaminated with Salmonella TyphimuriumEnvironmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0428-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0431-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0423-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-02-04Class IIPrima Vera Nueva, Inc.H-0432-2026Potential contamination with biological hazards (Listeria monocytogenes).Environmental Monitoring
2026-01-28Class IISouthern Rocklobster LTD USAH-0406-2026Potential Listeria Monocytogenes contaminationEnvironmental Monitoring
2026-01-21Class IIWhiteWave - Louisville Pilot PlantH-0398-2026Foreign materialEnvironmental Monitoring
2026-01-21Class IOrganic Living Superfoods LlcH-0393-2026Products may be contaminated with Salmonella Richmond.Environmental Monitoring
2026-01-21Class IIAdvanced Pharmaceutical Technology, Inc.D-0258-2026Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.Environmental Monitoring
2026-01-21Class IICipla USA, Inc.D-0290-2026Presence of Particulate Matter.Environmental Monitoring
2026-01-14Class IIImprimis NJOF, LLCD-0250-2026Presence of particulate matter - Glass like particles.Environmental Monitoring
2026-01-14Class IIImprimis NJOF, LLCD-0251-2026Presence of particulate matter - Glass like particles.Environmental Monitoring
2026-01-14Class IIImprimis NJOF, LLCD-0249-2026Presence of particulate matter - Glass like particles.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.