[ 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
2026-02-18Class ICarrot Top Kitchens LLCH-0488-2026Contains undeclared sesameDocumentation & Change Control
2026-02-18Class IMcKessonD-0353-2026Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.Documentation & Change Control
2026-02-18Class ICarrot Top Kitchens LLCH-0486-2026Contains undeclared sesameDocumentation & Change Control
2026-02-18Class IIIUnichem Pharmaceuticals USA Inc.D-0306-2026Tablets/Capsules Imprinted with Wrong IDDocumentation & Change Control
2026-02-18Class IIKarison Foods & Snacks, Inc.H-0506-2026Product contains milk, which is undeclared in the ingredient statement.Documentation & Change Control
2026-02-18Class IIKarison Foods & Snacks, Inc.H-0505-2026Product contains milk, which is undeclared in the ingredient statement.Documentation & Change Control
2026-02-18Class ICarrot Top Kitchens LLCH-0485-2026Contains undeclared sesameDocumentation & Change Control
2026-02-18Class IIIDomino Foods IncH-0497-2026Undeclared AspartameDocumentation & Change Control
2026-02-18Class ICarrot Top Kitchens LLCH-0489-2026Contains undeclared sesameDocumentation & Change Control
2026-02-18Class IICacao ArtH-0498-2026Undeclared allergen - milk. Product contains butter; cream is listed as a sub-ingredient of the butter, but milk is not declared in the ingredients or a contains statement.Documentation & Change Control
2026-02-18Class IIKPCM New York Inc.H-0490-2026Products contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40Documentation & Change Control
2026-02-18Class IIKarison Foods & Snacks, Inc.H-0508-2026Product contains milk, which is undeclared in the ingredient statement.Documentation & Change Control
2026-02-18Class IIKarison Foods & Snacks, Inc.H-0509-2026Product contains milk, which is undeclared in the ingredient statement.Documentation & Change Control
2026-02-18Class ICarrot Top Kitchens LLCH-0487-2026Contains undeclared sesameDocumentation & Change Control
2026-02-11Class IIIPrima Foods International, Inc.H-0443-2026Undeclared QuinineDocumentation & Change Control
2026-02-11Class IIRich Products CorpH-0440-2026Product contains undeclared milk and eggDocumentation & Change Control
2026-02-11Class IIBeacon Promotions IncH-0462-2026Undeclared allergens (milk, soy, and peanut)Documentation & Change Control
2026-02-11Class ITai Phat Wholesalers, LLCH-0459-2026Undeclared sulfitesDocumentation & Change Control
2026-02-11Class IVH FOODS INCH-0481-2026Undeclared allergens: egg and milkDocumentation & Change Control
2026-02-11Class IIImu-Tek Animal Health, IncorporatedH-0483-2026Undeclared milk allergenDocumentation & Change Control
2026-02-11Class IIIWilly Pete's Chocolate Company LLCH-0484-2026Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.Documentation & Change Control
2026-02-11Class IB.C. Williams Bakery Service, IncH-0501-2026Undeclared Milk AllergenDocumentation & Change Control
2026-02-11Class IIIPrima Foods International, Inc.H-0448-2026Undeclared QuinineDocumentation & Change Control
2026-02-11Class IIIPrima Foods International, Inc.H-0447-2026Undeclared QuinineDocumentation & Change Control
2026-02-11Class IIIPrima Foods International, Inc.H-0446-2026Undeclared QuinineDocumentation & 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.