[ 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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315 matching recalls
DateClassFirmReasonQuality domain
2025-10-22Class IIAscend Laboratories, LLCD-0020-2026Failed Dissolution SpecificationsValidation & Qualification
2025-10-15Class IIDr. Reddy's Laboratories, Inc.D-0008-2026Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.Validation & Qualification
2025-10-15Class IIAvKARED-0007-2026Failed Content Uniformity SpecificationsValidation & Qualification
2025-10-15Class IIAcella Pharmaceuticals, LLCD-0014-2026Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.Validation & Qualification
2025-10-15Class IIACCORD HEALTHCARE, INC.D-0006-2026Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.Validation & Qualification
2025-10-08Class IIAmerisource Health Services LLCD-0675-2025Failed Dissolution Specifications.Validation & Qualification
2025-10-08Class IIZydus Pharmaceuticals (USA) IncD-0002-2026Failed impurity/degradation specifications:Out of Specification result for an individual organic impurityValidation & Qualification
2025-10-08Class IIIStanley Pearlman Enterprises, Inc.H-0641-2025Recall initiated due to the wrong best by date (1-11-2025) being printed on the retail bag which would imply that these are expired but in truth they are good until 1-11-2027.Validation & Qualification
2025-10-08Class IIZydus Pharmaceuticals (USA) IncD-0001-2026Failed impurity/degradation specifications:Out of Specification result for an individual organic impurityValidation & Qualification
2025-10-01Class IIIGranules Pharmaceuticals Inc.D-0669-2025Failed Impurities/Degradation Specifications:Validation & Qualification
2025-10-01Class IIIGranules Pharmaceuticals Inc.D-0673-2025Failed Impurities/Degradation Specifications:Validation & Qualification
2025-10-01Class IIIMedline Industries, LPD-0674-2025Subpotent drugValidation & Qualification
2025-10-01Class IIIGranules Pharmaceuticals Inc.D-0670-2025Failed Impurities/Degradation Specifications:Validation & Qualification
2025-10-01Class IIIGranules Pharmaceuticals Inc.D-0671-2025Failed Impurities/Degradation Specifications:Validation & Qualification
2025-10-01Class IIIGranules Pharmaceuticals Inc.D-0672-2025Failed Impurities/Degradation Specifications:Validation & Qualification
2025-09-24Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0658-2025Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.Validation & Qualification
2025-09-24Class IIAscend Laboratories, LLCD-0645-2025Superpotent drugValidation & Qualification
2025-09-24Class IIZydus Pharmaceuticals (USA) IncD-0657-2025Failed Impurity/Degradation SpecificationsValidation & Qualification
2025-09-24Class IIZydus Pharmaceuticals (USA) IncD-0656-2025Failed Impurity/Degradation SpecificationsValidation & Qualification
2025-09-17Class IIGRACE & FIRE PTY LTDD-0641-2025Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.Validation & Qualification
2025-09-17Class IIExela Pharma Sciences LLCD-0620-2025Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.Validation & Qualification
2025-09-17Class IIZydus Pharmaceuticals (USA) IncD-0623-2025Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.Validation & Qualification
2025-09-17Class IIIDynamic Sports NutritionH-0573-2025Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.Validation & Qualification
2025-09-17Class IIGRACE & FIRE PTY LTDD-0640-2025Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.Validation & Qualification
2025-09-17Class IIBreckenridge Pharmaceutical, Inc.D-0621-2025CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Validation & Qualification
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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.