[ 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
2025-09-24Class IIAbdallah IncorporatedH-0580-2025Undeclared allergen (peanut, pecan).Documentation & Change Control
2025-09-24Class ILatitude 36 FoodsH-0605-2025Product contains undeclared Soy and SesameDocumentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0599-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIHARD EIGHT NUTRITION LLCH-0619-2025Finished product possibly contaminated with pathogenic Staphylococcus aureus.Environmental Monitoring
2025-09-24Class IIAbdallah IncorporatedH-0581-2025Undeclared allergen (peanut, pecan).Documentation & Change Control
2025-09-24Class IICheesecake Royale, Inc.H-0602-2025Review of Label determined allergen was listed as unsalted butter/ heavy cream. In one instance of identified label, there was no milk or dairy listed listed in Contains statement. Further review of label revealed "soy" had been removed.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0592-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IFresh & Ready Foods LLCH-0612-2025undeclared allergen (Wheat and Milk) on ready to eat sandwiches.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0586-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0594-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0591-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIItacate Foods LLCH-0649-2025Undeclared Yellow #5 and Yellow #6.Documentation & Change Control
2025-09-24Class IISouthwind Foods LLC dba Great American Seafood Imports Co.H-0603-2025Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0587-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0607-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0600-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0601-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0610-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0608-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IIItacate Foods LLCH-0648-2025Undeclared Yellow #5 and Yellow #6.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0597-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class INeuhaus nvH-0582-2025Product contains undeclared wheat.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0596-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class III C F Factory IncH-0635-2025May contained undeclared almondDocumentation & Change Control
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0609-2025Product contaminated with SalmonellaEnvironmental 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.