[ 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
2026-05-20Class IIAscend Laboratories, LLCD-0547-2026Failed Dissolution SpecificationsValidation & Qualification
2026-05-13Class IIAjanta Pharma Ltd.D-0515-2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Validation & Qualification
2026-05-13Class IIIUnichem Pharmaceuticals USA Inc.D-0511-2026Subpotent drugValidation & Qualification
2026-05-13Class IIBreckenridge Pharmaceutical, Inc.D-0522-2026CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitValidation & Qualification
2026-05-13Class IIJB Chemicals and Pharmaceuticals LtdD-0520-2026Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities TestValidation & Qualification
2026-05-13Class IIAjanta Pharma Ltd.D-0514-2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Validation & Qualification
2026-05-13Class IIAjanta Pharma Ltd.D-0516-2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Validation & Qualification
2026-05-06Class IIHikma Pharmaceuticals USA INCD-0526-2026This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.Validation & Qualification
2026-05-06Class IIIHeraeus Medical GmbH (Dental Division)Z-1997-2026Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).Validation & Qualification
2026-05-06Class IIIHeraeus Medical GmbH (Dental Division)Z-1998-2026Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).Validation & Qualification
2026-04-29Class IIXTANT Medical Holdings, IncZ-1897-2026Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.Validation & Qualification
2026-04-29Class IITeva Pharmaceuticals USA, IncD-0521-2026Failed Impurities/Degradation Specifications: Out of specification for specific impurity TretinoinValidation & Qualification
2026-04-29Class IIIPremier Dental Products CoD-0490-2026Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.Validation & Qualification
2026-04-29Class IIThe Harvard Drug Group LLCD-0493-2026Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.Validation & Qualification
2026-04-22Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0475-2026Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Validation & Qualification
2026-04-22Class IIThe Harvard Drug Group LLCD-0485-2026Failed Dissolution SpecificationsValidation & Qualification
2026-04-22Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0477-2026Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Validation & Qualification
2026-04-22Class II3B Medical, Inc.Z-1815-2026Devices which did not meet internal quality specifications were inadvertently distributed.Validation & Qualification
2026-04-22Class IIIIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0482-2026Subpotent DrugValidation & Qualification
2026-04-22Class IIIIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0480-2026Subpotent DrugValidation & Qualification
2026-04-22Class IIIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0487-2026Failed Stability SpecificationsValidation & Qualification
2026-04-22Class IIIAvantor Performance Materials LLCD-0488-2026Subpotent drugValidation & Qualification
2026-04-22Class IIIIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0481-2026Subpotent DrugValidation & Qualification
2026-04-22Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0476-2026Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.Validation & Qualification
2026-04-15Class IICook IncorporatedZ-1783-2026Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.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.