[ 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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743 matching recalls
DateClassFirmReasonQuality domain
2025-08-20Class IIThe Bonami Baking Company, Inc.H-0487-2025Undeclared milk from Contains statement.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0471-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0460-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0469-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IIIShang Hao Jia, IncH-0455-2025Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).Documentation & Change Control
2025-08-20Class IIIShang Hao Jia, IncH-0454-2025Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).Documentation & Change Control
2025-08-20Class IIThe Bonami Baking Company, Inc.H-0490-2025Undeclared wheat and milk from sub-ingredients.Documentation & Change Control
2025-08-20Class IIIShang Hao Jia, IncH-0453-2025Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).Documentation & Change Control
2025-08-20Class IIThe Bonami Baking Company, Inc.H-0488-2025Undeclared milk and soy (from soy lecithin) from sub-ingredients.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0466-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0470-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0461-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0458-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0468-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-20Class IIThe Bonami Baking Company, Inc.H-0489-2025Undeclared milk and/or eggs from sub-ingredients and/or Contains statement.Documentation & Change Control
2025-08-20Class IIThe Bonami Baking Company, Inc.H-0491-2025Undeclared wheat, milk, and soy (from soy lecithin) from sub-ingredients.Documentation & Change Control
2025-08-20Class IITropicale Foods, LLCH-0459-2025Product label includes the ingredient CREAM but does not include Milk as the source.Documentation & Change Control
2025-08-13Class IIDistinctive Foods LLCH-0456-2025Undeclared sesame.Documentation & Change Control
2025-08-13Class IICesarina Bakery, IncH-0392-2025Allergen not listed in the Contains statement: SesameDocumentation & Change Control
2025-08-13Class IIICesarina Bakery, IncH-0393-2025Allergen not listed in the Contains statement: SesameDocumentation & Change Control
2025-08-13Class IICardinal Health Inc.D-0573-2025CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Documentation & Change Control
2025-08-13Class IICardinal Health Inc.D-0572-2025CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Documentation & Change Control
2025-08-13Class IICardinal Health Inc.D-0571-2025CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.Documentation & Change Control
2025-08-13Class IIIStickney Hill Dairy, LLCH-0388-2025Package has incorrect Use By date.Documentation & Change Control
2025-08-06Class IIReisman Bros BakeryH-0358-2025Undeclared wheatDocumentation & 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.