[ 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
2026-04-01Class IINRS Enterprises, Inc. dba Sunflour BakeryH-0603-2026Undeclared sesame seed ingredient in hamburger buns.Documentation & Change Control
2026-04-01Class IISouth Florida Food, LLCH-0623-2026Undeclared Soy.Documentation & Change Control
2026-04-01Class IISavannah Bee Company Inc.H-0615-2026Undeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard", but the product inside the bottle is a different flavor of BBQ sauce. After investigation, the firm determined that the product in the bottle is their Honey BBQ Sauce "Sweet". The BBQ sauce "Sweet" contains wheat and soy which is not listed on the BBQ Sauce "Mustard" label.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1621-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IILidl US TRADINGH-0631-2026Label does not specify type of tree nut contained in the product.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1623-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1627-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IICareFusion 303, Inc.Z-1645-2026Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care UnitsDocumentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1625-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1626-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-03-25Class IShaman Botanicals, LLCH-1108-2026A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.Documentation & Change Control
2026-03-25Class IIStryker Medical Division of Stryker CorporationZ-1580-2026Cribs sold in the USA are missing two access door warning labels.Documentation & Change Control
2026-03-25Class IILeMaitre Vascular, Inc.Z-1574-2026Labeling mix-up resulting in the incorrect lot outer packaging of product.Documentation & Change Control
2026-03-25Class IIASUKAR FOODS CORPH-0584-2026Undeclared allergen: Soy LecithinDocumentation & Change Control
2026-03-25Class IShaman Botanicals, LLCH-1107-2026A sample of the product had the active ingredient in a quantity greater than the labeled specification.Documentation & Change Control
2026-03-25Class IFRITO-LAY NORTH AMERICA, INC.H-0571-2026Undeclared Allergen: MilkDocumentation & Change Control
2026-03-25Class IKradjian Importing Company, Inc.H-0576-2026Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.Documentation & Change Control
2026-03-25Class IDreamland IncH-0575-2026Undeclared Sesame, Soy, WheatDocumentation & Change Control
2026-03-18Class IIITipp Distributors, Inc. dba NovamexH-0545-2026The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.Documentation & Change Control
2026-03-18Class IICocos Wholesale and Imports, LLCH-0553-2026Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheatDocumentation & Change Control
2026-03-18Class IIPalmetto Gourmet Foods Inc.H-0547-2026Product contains undeclared Yellow #5Documentation & Change Control
2026-03-18Class IICocos Wholesale and Imports, LLCH-0554-2026Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does not declare wheat or milk.Documentation & Change Control
2026-03-18Class IICNC Noodle CorporationH-0613-2026Undeclared wheat.Documentation & Change Control
2026-03-18Class IHouse Of Flavors, Inc.H-0621-2026Undeclared eggDocumentation & Change Control
2026-03-18Class IIUncle Ray's LLCH-0552-2026Inaccurate nutritional data in Nutrition Facts including but not limited to, understated sodium content. Undeclared ingredients including but not limited to, monosodium glutamate.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.