[ 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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758 matching recalls
DateClassFirmReasonQuality domain
2025-10-08Class IIGina Marie Bakery LLCH-0008-2026Undeclared Red 3 and Blue 1Documentation & Change Control
2025-10-08Class IWFM Purchasing, LPH-0002-2026Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew.Documentation & Change Control
2025-10-08Class IIIGina Marie Bakery LLCH-0009-2026Contains undeclared Red 40Documentation & Change Control
2025-10-01Class IGooder Foods, Inc.H-0028-2026Undeclared allergens (cashews).Documentation & Change Control
2025-10-01Class IGooder Foods, Inc.H-0027-2026Undeclared allergens (milk).Documentation & Change Control
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 IIIHi-Tech Pharmaceuticals Inc.H-0595-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0598-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class III C F Factory IncH-0635-2025May contained undeclared almondDocumentation & Change Control
2025-09-24Class IIAmerisource Health Services LLCD-0650-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0590-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class INeuhaus nvH-0582-2025Product contains undeclared wheat.Documentation & Change Control
2025-09-24Class IINorthwind Pharmaceuticals LLCD-0654-2025Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-24Class IUnichem Pharmaceuticals USA Inc.D-0655-2025Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0593-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IFresh & Ready Foods LLCH-0615-2025undeclared allergen (Wheat) on ready to eat sandwiches.Documentation & Change Control
2025-09-24Class IFresh & Ready Foods LLCH-0614-2025undeclared allergen (Wheat and Milk) on ready to eat sandwiches.Documentation & Change Control
2025-09-24Class IIAmerisource Health Services LLCD-0647-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-24Class IIAmerisource Health Services LLCD-0649-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-24Class IIAmerisource Health Services LLCD-0648-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0596-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0597-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-24Class IIItacate Foods LLCH-0648-2025Undeclared Yellow #5 and Yellow #6.Documentation & Change Control
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0588-2025Unapproved Drug Claims and Misbranded.Documentation & 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.