[ 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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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-04-01Class IIPacific Coast Fresh COH-0608-2026Foreign material (aluminum pieces).Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0595-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-04-01Class IIPacific Coast Fresh COH-0604-2026Foreign material (aluminum pieces).Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0593-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-04-01Class IIAmerican Laboratories, LLCH-0612-2026Potential Salmonella contamination.Environmental Monitoring
2026-04-01Class IIPacific Coast Fresh COH-0605-2026Foreign material (aluminum pieces).Environmental Monitoring
2026-04-01Class IIBakkavorH-0619-2026Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0597-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0592-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0600-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-04-01Class IIWestern Mixers Produce & Nuts, Inc.H-0590-2026Foreign object (glass) found inside sealed container of finished product.Environmental Monitoring
2026-04-01Class IIRose and Shore, Inc.H-0622-2026potential foreign object (metal pieces) in ingredient (Tomatoes)Environmental Monitoring
2026-04-01Class IIAjinomoto Foods North America Inc.H-0599-2026Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.Environmental Monitoring
2026-03-25Class ICardinal Health 200, LLCD-0528-2026Non-Sterility: microbial contamination identified as Paenibacillus phoenicisEnvironmental Monitoring
2026-03-25Class IIApotex Corp.D-0407-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-25Class IIDr. Praeger's Sensible Foods Inc.H-0570-2026This product has the possibility of contamination with rodent hair.Environmental Monitoring
2026-03-25Class IBluegrass Ingredients Inc.H-0573-2026Positive Salmonella contaminationEnvironmental Monitoring
2026-03-25Class IBluegrass Ingredients Inc.H-0572-2026Potential Salmonella contaminationEnvironmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0560-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0566-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IAmbrosia Brands LLCH-0546-2026Product may be contaminated with SalmonellaEnvironmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0558-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0562-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0568-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0565-2026Products may be contaminated with Listeria monocytogenes.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.