[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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 IIIHi-Tech Pharmaceuticals Inc.H-0591-2025Unapproved Drug Claims.Documentation & Change Control
2025-09-24Class IIItacate Foods LLCH-0648-2025Undeclared Yellow #5 and Yellow #6.Documentation & Change Control
2025-09-17Class IWegmans Food Markets, Inc.H-0571-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IIIDynamic Sports NutritionH-0573-2025Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.Validation & Qualification
2025-09-17Class IIHERSHEY CREAMERY CO.H-0579-2025Product tested elevated coliform counts during routine testingEnvironmental Monitoring
2025-09-17Class IIAnderson Candy Company, LLCH-0578-2025Undeclared soy allergenDocumentation & Change Control
2025-09-17Class IWegmans Food Markets, Inc.H-0570-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0572-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0569-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IIM.O.M Enterprises, LLC.H-0576-2025Potential for spoilage due to yeast contamination.Environmental Monitoring
2025-09-10Class IIThe Candy BarnH-0565-2025Allergen labeling: specific tree nut (pecans) not listed in the 'contains' statementDocumentation & Change Control
2025-09-10Class IIEvergreen Orchard Farm, LLCH-0555-2025Lack of pasteurization and sanitation records—
2025-09-10Class IIThe Candy BarnH-0563-2025Allergen labeling: egg not listed in the 'contains' statementDocumentation & Change Control
2025-09-10Class IITAMPA MAID FOODS, LLCH-0551-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IIThe Candy BarnH-0560-2025Allergen labeling: specific tree nut (walnut) and egg are not listed in the 'contains' statementDocumentation & Change Control
2025-09-10Class IIEvergreen Orchard Farm, LLCH-0557-2025Lack of pasteurization and sanitation records—
2025-09-10Class IIThe Candy BarnH-0561-2025Allergen labeling: egg is not listed in the 'contains' statementDocumentation & Change Control
2025-09-10Class ITaylor Farms Retail, Inc.H-0616-2025Undeclared allergens (sesame and soy).Documentation & Change Control
2025-09-10Class IIThe Candy BarnH-0567-2025Allergen labeling: specific tree nut (pecan) not listed in 'contains' statementDocumentation & 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 IITAMPA MAID FOODS, LLCH-0553-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IITAMPA MAID FOODS, LLCH-0552-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IINIRWANA FOODS LLCH-0554-2025Undeclared Sulfites in productDocumentation & Change Control
2025-09-10Class IIThe Candy BarnH-0566-2025Allergen labeling: missing allergens (peanuts, milk) in contains statementDocumentation & Change Control
2025-09-10Class IIThe Candy BarnH-0559-2025Allergen labeling: egg is not listed in the 'contains' statementDocumentation & 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.