[ 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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1,475 matching recalls
DateClassFirmReasonQuality domain
2026-01-14Class IIRovira Biscuit CorporationH-0358-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIDIRECT SOURCE SEAFOOD LLCH-0380-2026Shrimp may be contaminated with Cesium-137 (Cs-137).Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0373-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIFresh & Ready Foods LLCH-0356-2026Foreign material.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0367-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0370-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIRovira Biscuit CorporationH-0362-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0363-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IAmbriola Co., Inc., TheH-0374-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0368-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IID. Coluccio & Sons Inc.H-0366-2026Contains elevated levels of hydrocyanic acid—
2026-01-14Class IIRovira Biscuit CorporationH-0360-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIMcCain Foods USA IncH-0376-2026Clear hard plastic fragments.—
2026-01-14Class ILund Food Holdings IncH-0352-2026Undeclared allergens (Peanut, Egg, Soy)Documentation & Change Control
2026-01-14Class IIFresh & Ready Foods LLCH-0354-2026Foreign material.Environmental Monitoring
2026-01-14Class IGBC Food Services, LLCH-0381-2026Potential presence of Listeria monocytogenes.Environmental Monitoring
2026-01-14Class IITown Food Service Equip Co IncH-0351-2026Product found to contain leachable lead levels.—
2026-01-14Class IAmbriola Co., Inc., TheH-0371-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIZIYAD BROTHERS IMPORTINGH-0377-2026May contain partially hydrogenated oils—
2026-01-14Class IIFresh & Ready Foods LLCH-0353-2026Foreign material.Environmental Monitoring
2026-01-14Class IIMcCain Foods USA IncH-0375-2026Clear hard plastic fragments.—
2026-01-14Class IIMAYEJ COMERCIALIZADORA S. de R.L. de C.V.H-0392-2026pathogen Cyclospora cayetanensisEnvironmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0372-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIZIYAD BROTHERS IMPORTINGH-0378-2026May contain partially hydrogenated oils—
2026-01-14Class ISouth Asian Food Inc.H-0410-2026Contains undeclared peanutsDocumentation & Change Control
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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.