[ 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 |
|---|---|---|---|---|
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0609-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0606-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | IMMUNOCORE, LLCD-0614-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0608-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class III | Boothwyn Pharmacy LLCD-0607-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0605-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0602-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0603-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0601-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0604-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0600-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-08-27 | Class III | Cipla USA, Inc.D-0593-2025 | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Validation & Qualification |
| 2025-08-27 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0594-2025 | 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 | Glenmark Pharmaceuticals Inc., USAD-0583-2025 | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria. | Validation & Qualification |
| 2025-08-20 | Class III | GMP Laboratories of America IncH-0448-2025 | Downstream recall of a dietary supplement ingredient that was manufactured out of specification. | Validation & Qualification |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0442-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | PfizerD-0575-2025 | Subpotent drug | Validation & Qualification |
| 2025-08-20 | Class II | Glenmark Pharmaceuticals Inc., USAD-0587-2025 | 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 | Glenmark Pharmaceuticals Inc., USAD-0578-2025 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Validation & Qualification |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0446-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | Merck & Co. IncD-0584-2025 | Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. | Validation & Qualification |
| 2025-08-20 | Class III | GMP Laboratories of America IncH-0447-2025 | Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. | Validation & Qualification |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0445-2025 | 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-0577-2025 | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. | Validation & Qualification |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0444-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
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.