[ 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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1,475 matching recalls
DateClassFirmReasonQuality domain
2026-01-28Class IICATAO MARKET LLCH-0413-2026Undeclared colors FD&C Yellow #5Documentation & Change Control
2026-01-21Class IHerbs ForeverH-0405-2026Potential undeclared allergen ingredient (Wheat)Documentation & Change Control
2026-01-21Class IIWhiteWave - Louisville Pilot PlantH-0398-2026Foreign materialEnvironmental Monitoring
2026-01-21Class IIEUREKA INCH-0388-2026Elevated levels of lead.—
2026-01-21Class IIHouse Of Flavors, Inc.H-0383-2026Undeclared soy lecithinDocumentation & Change Control
2026-01-21Class IIIASK Foods IncH-0385-2026Undeclared Allergen (Soy)Documentation & Change Control
2026-01-21Class IIMangalm LLCH-0386-2026Unapproved color (carmoisine).Documentation & Change Control
2026-01-21Class IWFM Purchasing, LPH-0403-2026Undeclared Fish and Egg AllergenDocumentation & Change Control
2026-01-21Class IISanders Candy Factory IncH-0394-2026elevated levels of aflatoxin—
2026-01-21Class IIHouse Of Flavors, Inc.H-0384-2026Undeclared soy lecithinDocumentation & Change Control
2026-01-21Class IOrganic Living Superfoods LlcH-0393-2026Products may be contaminated with Salmonella Richmond.Environmental Monitoring
2026-01-21Class IIMangalm LLCH-0387-2026Unapproved color (carmoisine).Documentation & Change Control
2026-01-21Class IIGUSTO GROUP, INC.H-0390-2026Product tested high for lead.—
2026-01-21Class IIGUSTO GROUP, INC.H-0389-2026Product tested high for lead.—
2026-01-21Class IHerbs ForeverH-0404-2026Potential undeclared allergen ingredient (Wheat)Documentation & Change Control
2026-01-21Class IIUkrop's Homestyle Foods, LLCH-0395-2026Undeclared Soy. Label did not include soy, which was used in product.Documentation & Change Control
2026-01-21Class IIUkrop's Homestyle Foods, LLCH-0396-2026Undeclared Soy. Label did not include soy, which was used in product.Documentation & Change Control
2026-01-21Class IOne Roof LLCH-0402-2026Undeclared tree nut allergens: almonds, pecans, and walnuts.Documentation & Change Control
2026-01-21Class IIUkrop's Homestyle Foods, LLCH-0397-2026Undeclared Soy. Label did not include soy, which was used in product.Documentation & Change Control
2026-01-21Class IIAZ Gems, Inc.H-0401-2026elevated levels of chloramphenicol in frozen shrimp—
2026-01-21Class IFran's Chocolates LtdH-0399-2026undeclared hazelnut.Documentation & Change Control
2026-01-21Class ITroemner FarmH-0400-2026undeclared soy, wheat, milkDocumentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0359-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class ISam Dry Fruits and Nuts Enterprises, IncH-0357-2026Potential contamination with Salmonella.Environmental Monitoring
2026-01-14Class IIRovira Biscuit CorporationH-0361-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & 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.