[ 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
2025-10-15Class IIEgress Capital Partners Inc.H-0014-2026No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)Documentation & Change Control
2025-10-15Class IIEgress Capital Partners Inc.H-0016-2026No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)Documentation & Change Control
2025-10-15Class IIEgress Capital Partners Inc.H-0015-2026No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)Documentation & Change Control
2025-10-15Class IIEgress Capital Partners Inc.H-0017-2026No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)Documentation & Change Control
2025-10-15Class IIEgress Capital Partners Inc.H-0018-2026No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)Documentation & Change Control
2025-10-15Class ILee K of NY Inc.H-0024-2026Product contains undeclared milk and shrimpDocumentation & Change Control
2025-10-15Class IINew Spirit Naturals Inc.H-0022-2026undeclared allergen ingredient Milk.Documentation & Change Control
2025-10-15Class IHarris TeeterH-0029-2026Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.Documentation & Change Control
2025-10-15Class IIEden¿¿¿s Elixirs, LLCH-0130-2026Undeclared Yellow #5Documentation & Change Control
2025-10-15Class IINew Spirit Naturals Inc.H-0021-2026undeclared allergen ingredient Milk.Documentation & Change Control
2025-10-15Class IIIGansu Zhaofeng Agricultural Development Co., Ltd.H-0111-2026Undeclared allergen (wheat).Documentation & Change Control
2025-10-15Class IIEden¿¿¿s Elixirs, LLCH-0131-2026Undeclared Yellow #5Documentation & Change Control
2025-10-15Class IIIDEMERS FOOD GROUP LLCH-0046-2026contains undeclared wheatDocumentation & Change Control
2025-10-15Class IINew Spirit Naturals Inc.H-0019-2026undeclared allergen ingredient Milk.Documentation & Change Control
2025-10-15Class IHarris TeeterH-0030-2026Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.Documentation & Change Control
2025-10-15Class IINew Spirit Naturals Inc.H-0020-2026undeclared allergen ingredient Milk.Documentation & Change Control
2025-10-15Class IIEden¿¿¿s Elixirs, LLCH-0129-2026Undeclared Yellow #5Documentation & Change Control
2025-10-08Class IIPepsico IncH-0010-2026Undeclared sugar in finished product-primary package does not reflect the product inside bottle.Documentation & Change Control
2025-10-08Class IIIGina Marie Bakery LLCH-0005-2026Undeclared Red 40Documentation & Change Control
2025-10-08Class IIVitalabs, Inc.H-0037-2026Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.Documentation & Change Control
2025-10-08Class IIIGina Marie Bakery LLCH-0007-2026Undeclared Red 40Documentation & Change Control
2025-10-08Class IIOven Artisans llcH-0001-2026Mislabeled: Product may contain undeclared sesame seedsDocumentation & Change Control
2025-10-08Class IIGina Marie Bakery LLCH-0003-2026Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1Documentation & Change Control
2025-10-08Class IIGina Marie Bakery LLCH-0004-2026Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6Documentation & Change Control
2025-10-08Class IIGina Marie Bakery LLCH-0006-2026Undeclared Red 40 and Yellow 6Documentation & 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.