[ 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.
315 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0443-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | Glenmark Pharmaceuticals Inc., USAD-0588-2025 | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm | Validation & Qualification |
| 2025-08-20 | Class II | Breckenridge Pharmaceutical, Inc.D-0580-2025 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Validation & Qualification |
| 2025-08-20 | Class II | Glenmark Pharmaceuticals Inc., USAD-0579-2025 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Validation & Qualification |
| 2025-08-20 | Class II | Ascend Laboratories, LLCD-0576-2025 | Failed Dissolution Specifications: low dissolution results | Validation & Qualification |
| 2025-08-13 | Class II | Alembic Pharmaceuticals LimitedD-0566-2025 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Validation & Qualification |
| 2025-08-13 | Class II | Direct RxD-0568-2025 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Validation & Qualification |
| 2025-08-13 | Class II | Direct RxD-0567-2025 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Validation & Qualification |
| 2025-08-13 | Class II | Breckenridge Pharmaceutical, Inc.D-0552-2025 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Validation & Qualification |
| 2025-08-06 | Class II | Strides Pharma, Inc.D-0546-2025 | Failed Dissolution Specifications. | Validation & Qualification |
| 2025-08-06 | Class II | Hikma Pharmaceuticals USA Inc.D-0551-2025 | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Validation & Qualification |
| 2025-08-06 | Class II | Lupin Pharmaceuticals Inc.D-0542-2025 | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 | Validation & Qualification |
| 2025-07-30 | Class II | Imprimis NJOF, LLCD-0535-2025 | Sub-Potent Drug: Subpotent assay results during stability testing. | Validation & Qualification |
| 2025-07-30 | Class II | Lupin Pharmaceuticals Inc.D-0537-2025 | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. | Validation & Qualification |
| 2025-07-30 | Class III | Imprimis NJOF, LLCD-0536-2025 | Sub-Potent Drug: Subpotent assay results during stability testing. | 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.