[ 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
2025-09-24Class IIIHi-Tech Pharmaceuticals Inc.H-0589-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IFresh & Ready Foods LLCH-0613-2025undeclared allergen (Wheat and Milk) on ready to eat sandwiches.Documentation & Change Control
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 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 IIIHi-Tech Pharmaceuticals Inc.H-0587-2025Unapproved Drug Claims and Misbranded.Documentation & Change Control
2025-09-17Class IIAnderson Candy Company, LLCH-0578-2025Undeclared soy allergenDocumentation & Change Control
2025-09-17Class IIThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0625-2025Presence 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
2025-09-17Class IILannett Company Inc.D-0642-2025Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.Documentation & Change Control
2025-09-17Class IIThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0624-2025Presence 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
2025-09-10Class IIAmneal Pharmaceuticals, LLCD-0616-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-10Class IIAmneal Pharmaceuticals, LLCD-0619-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-10Class IIAmneal Pharmaceuticals, LLCD-0617-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-10Class IIAmneal Pharmaceuticals, LLCD-0618-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-10Class IIAmneal Pharmaceuticals, LLCD-0615-2025Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.Documentation & Change Control
2025-09-10Class IIThe Candy BarnH-0562-2025Allergen labeling: specific tree nut (pecan) and egg are not listed in the 'contains' statementDocumentation & Change Control
2025-09-10Class IINIRWANA FOODS LLCH-0554-2025Undeclared Sulfites in productDocumentation & 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.