[ 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.

Reset
758 matching recalls
DateClassFirmReasonQuality domain
2025-12-10Class IISafecor Health, LLCD-0214-2026Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.Documentation & Change Control
2025-12-10Class IIDreyer's Grand Ice Cream, Inc.H-0227-2026Undeclared wheat.Documentation & Change Control
2025-12-03Class IIJeni's Splendid Ice Creams LLCH-0207-2026Undeclared allergens - wheat and soyDocumentation & Change Control
2025-12-03Class IINats Nuts LLCH-0206-2026Contains undeclared cashewsDocumentation & Change Control
2025-11-26Class IPlenus Group Inc.H-0201-2026Products contain undeclared shrimp (crustacean shellfish)Documentation & Change Control
2025-11-26Class IOtsuka ICU Medical LLCD-0180-2026Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEqDocumentation & Change Control
2025-11-26Class IOtsuka ICU Medical LLCD-0181-2026Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEqDocumentation & Change Control
2025-11-26Class IPublix Super Markets, Inc.H-0192-2026Undeclared EggsDocumentation & Change Control
2025-11-19Class IZingerman's Coffee CompanyH-0179-2026Undeclared peanutDocumentation & Change Control
2025-11-19Class ISeoul Trading, Inc.H-0191-2026Undeclared peanut.Documentation & Change Control
2025-11-19Class IIHANA GROUPH-0209-2026Wheat and Soy missing allergens from the product Contains Statement.Documentation & Change Control
2025-11-19Class IZingerman's Coffee CompanyH-0178-2026Undeclared cashewDocumentation & Change Control
2025-11-19Class IIBlue Oven Bakery, Inc.H-0173-2026Undeclared allergen - milkDocumentation & Change Control
2025-11-12Class ITeasdale Foods, Inc.H-0156-2026Undeclared allergen - milkDocumentation & Change Control
2025-11-12Class IIAero HealthcareD-0155-2026Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.Documentation & Change Control
2025-11-12Class INew York Mutual Trading, Inc.H-0147-2026Undeclared allergen ingredients (fish, soy, and wheat)Documentation & Change Control
2025-11-12Class IIQUE RIKURA'S PRODUCTS, CORPH-0152-2026Undeclared sulfites in product label.Documentation & Change Control
2025-11-12Class ITeasdale Foods, Inc.H-0155-2026Undeclared allergen - milkDocumentation & Change Control
2025-11-12Class IIQuality Poultry & Seafood IncH-0148-2026Undeclared Yellow 5, Yellow 6Documentation & Change Control
2025-11-05Class IWeaver Nut Company, IncH-0135-2026undeclared milk allergenDocumentation & Change Control
2025-11-05Class IIACME UNITED CORPORATIOND-0122-2026Product Mix-upDocumentation & Change Control
2025-11-05Class IIILetco Medical LLCD-0138-2026Labeling: Not Elsewhere ClassifiedDocumentation & Change Control
2025-11-05Class ITai Foong USA IncH-0143-2026Undeclared shrimpDocumentation & Change Control
2025-11-05Class IDoan's Dessert And CoffeeH-0138-2026Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.Documentation & Change Control
2025-11-05Class IDoan's Dessert And CoffeeH-0137-2026Undeclared allergen ingredient (Wheat) in Ready-to-eat frozen cakes.Documentation & Change Control
Page 21 of 31
← PrevNext →

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.