[ 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
2026-01-21Class IIMangalm LLCH-0386-2026Unapproved color (carmoisine).Documentation & Change Control
2026-01-21Class IHerbs ForeverH-0404-2026Potential undeclared allergen ingredient (Wheat)Documentation & Change Control
2026-01-21Class IFran's Chocolates LtdH-0399-2026undeclared hazelnut.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 ITroemner FarmH-0400-2026undeclared soy, wheat, milkDocumentation & 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 IIMangalm LLCH-0387-2026Unapproved color (carmoisine).Documentation & Change Control
2026-01-21Class IIAlvogen, IncD-0259-2026Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.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 IWFM Purchasing, LPH-0403-2026Undeclared Fish and Egg AllergenDocumentation & Change Control
2026-01-21Class IIHouse Of Flavors, Inc.H-0384-2026Undeclared soy lecithinDocumentation & Change Control
2026-01-21Class IHerbs ForeverH-0405-2026Potential undeclared allergen ingredient (Wheat)Documentation & Change Control
2026-01-21Class IIHouse Of Flavors, Inc.H-0383-2026Undeclared soy lecithinDocumentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0360-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0363-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0362-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0358-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0361-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-14Class ISouth Asian Food Inc.H-0410-2026Contains undeclared peanutsDocumentation & Change Control
2026-01-14Class ILund Food Holdings IncH-0352-2026Undeclared allergens (Peanut, Egg, Soy)Documentation & Change Control
2026-01-14Class IIRovira Biscuit CorporationH-0359-2026Undeclared colors FD&C Yellow #6, and FD&C Red 40Documentation & Change Control
2026-01-07Class IIIBendon PublishingH-0350-2026Unapproved color additive - chlorophyllin copper complexDocumentation & Change Control
2026-01-07Class IIGlenmark Pharmaceuticals Inc., USAD-0246-2026Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.Documentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0347-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & 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.