[ 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
2026-06-17Class IIGalaxy RG CorpH-0936-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIFresenius Medical Care Holdings, Inc.Z-2401-2026There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.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 IIGalaxy RG CorpH-0934-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0923-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0933-2026Undeclared 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-0917-2026Undeclared 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 IIIRefresqueria Estrella Inc.H-0913-2026Undeclared FD&C Red 40Documentation & Change Control
2026-06-17Class IIHF Acquisition Co LLCZ-2332-2026Due to incorrect incubation process being performed on product.Documentation & Change Control
2026-06-17Class IIBEF Foods, IncH-0940-2026Undeclared allergen (soy lecithin).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0928-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-10Class IHometown Food CompanyH-0903-2026Undeclared eggDocumentation & Change Control
2026-06-10Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0599-2026Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaDocumentation & Change Control
2026-06-10Class IIJ and J Bunting, IncH-0914-2026Sesame Seeds White were labeled as Curry Powder Sweet.Documentation & Change Control
2026-06-10Class IIThe Brownie Baker Inc.H-0859-2026Undeclared walnutsDocumentation & Change Control
2026-06-10Class IWilco Peanut CoH-0906-2026Undeclared Tree Nut AllergenDocumentation & Change Control
2026-06-10Class IIIEugia US LLCD-0552-2026Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scanDocumentation & Change Control
2026-06-10Class IIGrace Medical, Inc.Z-2308-2026Due to incorrect functional length on device labeling.Documentation & Change Control
2026-06-10Class IICovidien LLCZ-2261-2026Due to customer complaint regarding incorrect display box labeling.Documentation & Change Control
2026-06-10Class IISSC- Surgical Specialties CorporationZ-2309-20263.0mm surgical knives labeled and packaged as 2.2mm surgical knives.Documentation & Change Control
2026-06-10Class IISECOND NATURE BRANDH-0905-2026The product may contain undeclared allergens (cashews, pistachios), and dried cherries.Documentation & Change Control
2026-06-10Class IIMarket of Choice IncH-0904-2026Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.Documentation & Change Control
2026-06-10Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0598-2026Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name XyvonaDocumentation & 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.