[ 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
2026-06-24Class IIHowmedica Osteonics Corp.Z-2462-2026Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).Documentation & Change Control
2026-06-24Class IIUnited States BakeryH-0949-2026Firm observed oily and sticky substance on direct food contact surface packaging of finished product.Documentation & Change Control
2026-06-24Class IIHowmedica Osteonics Corp.Z-2461-2026Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).Documentation & Change Control
2026-06-17Class IIIRefresqueria Estrella Inc.H-0913-2026Undeclared FD&C Red 40Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0929-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0934-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0926-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0920-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0919-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0937-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0936-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0916-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIBEF Foods, IncH-0940-2026Undeclared allergen (soy lecithin).Documentation & Change Control
2026-06-17Class IE & S Grocery & Bakery Inc.H-0944-2026Undeclared Egg AllergenDocumentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0931-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIIWeikfield Foods Pvt. Ltd.H-0911-2026The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.Documentation & Change Control
2026-06-17Class IKettle Cuisine, LLCH-0941-2026Contains undeclared allergen (shrimp).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0932-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0930-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0922-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0935-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0927-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0915-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0924-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0925-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).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.