[ 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
2026-03-11Class IIHTO Nevada Inc. dba KirkmanD-0386-2026Stability Data Does Not Support Expiry Date.Validation & Qualification
2026-03-11Class IIICipla USA, Inc.D-0381-2026Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.Validation & Qualification
2026-03-11Class IITeva Pharmaceuticals USA, IncD-0357-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IITeva Pharmaceuticals USA, IncD-0354-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IITeva Pharmaceuticals USA, IncD-0356-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IIMYLAN PHARMACEUTICALS INCD-0399-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IIRising Pharma Holding, Inc.D-0384-2026Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testingValidation & Qualification
2026-03-04Class IIAvKARED-0341-2026Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.Validation & Qualification
2026-02-11Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0342-2026Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.Validation & Qualification
2026-02-11Class IIUnichem Pharmaceuticals USA Inc.D-0301-2026cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.Validation & Qualification
2026-02-04Class IIINOVADOZ PHARMACEUTICALS LLCD-0300-2026Failed Impurities/Degradation SpecificationsValidation & Qualification
2026-02-04Class IIIHaleon US Holdings LLCD-0297-2026Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.Validation & Qualification
2026-01-28Class IIZydus Pharmaceuticals (USA) IncD-0295-2026Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsulesValidation & Qualification
2026-01-28Class IISpecialty Process Labs LLCD-0294-2026Subpotent DrugValidation & Qualification
2026-01-21Class IIISUN PHARMACEUTICAL INDUSTRIES INCD-0257-2026Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.Validation & Qualification
2026-01-21Class IIISUN PHARMACEUTICAL INDUSTRIES INCD-0256-2026Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.Validation & Qualification
2026-01-14Class IIAvKARED-0292-2026Out of specification for dissolution.Validation & Qualification
2026-01-14Class IIIAlembic Pharmaceuticals LimitedD-0248-2026Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Validation & Qualification
2025-12-24Class IISUN PHARMA /TAROD-0240-2026Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepointValidation & Qualification
2025-12-24Class IIISOMERSET THERAPEUTICS LLCD-0238-2026Subpotent product:out of specification assay results observed during long term stability testing.Validation & Qualification
2025-12-24Class IIISOMERSET THERAPEUTICS LLCD-0236-2026Subpotent product:out of specification assay results observed during long term stability testing.Validation & Qualification
2025-12-24Class IIISOMERSET THERAPEUTICS LLCD-0237-2026Subpotent product:out of specification assay results observed during long term stability testing.Validation & Qualification
2025-12-17Class IICipla USA, Inc.D-0218-2026Failed stability specifications: Out of specification for hardness testValidation & Qualification
2025-12-17Class IICipla USA, Inc.D-0217-2026Failed stability specifications: Out of specification for hardness testValidation & Qualification
2025-12-17Class IILupin Pharmaceuticals Inc.D-0220-2026Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.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.