[ 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.
832 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 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-0604-2025 | 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 | Baxter Healthcare CorporationD-0596-2025 | Discoloration | — |
| 2025-09-03 | Class II | Lannett Company Inc.D-0599-2025 | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. | Documentation & Change Control |
| 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 | Cardinal Health Inc.D-0597-2025 | Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL | Documentation & Change Control |
| 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 II | VIONA PHARMACEUTICALS INCD-0595-2025 | Discoloration | — |
| 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 |
| 2025-08-27 | Class II | Taizhou Kangping Medical Science And Technology Co., Ltd.D-0589-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-08-27 | Class II | PFIZER INCD-0590-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 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 III | Haleon US Holdings LLCD-0592-2025 | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton | Documentation & Change Control |
| 2025-08-27 | Class II | PFIZER INCD-0591-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 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 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-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 II | Ascend Laboratories, LLCD-0576-2025 | Failed Dissolution Specifications: low dissolution results | 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 II | Westminster Pharmaceuticals LLCD-0582-2025 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Risk Management & CAPA |
| 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 | B BRAUN MEDICAL INCD-0586-2025 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Environmental Monitoring |
| 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 II | Westminster Pharmaceuticals LLCD-0581-2025 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Risk Management & CAPA |
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.