[ 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 |
|---|---|---|---|---|
| 2025-08-20 | 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-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 | 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 | B BRAUN MEDICAL INCD-0585-2025 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Environmental Monitoring |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0560-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0557-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | Cardinal Health Inc.D-0571-2025 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Documentation & Change Control |
| 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 | AEQUITA PHARMACYD-0562-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 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 | 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 | Breckenridge Pharmaceutical, Inc.D-0552-2025 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Validation & Qualification |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0559-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0556-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0561-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0553-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0555-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | Cardinal Health Inc.D-0572-2025 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Documentation & Change Control |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0564-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0563-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0565-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0554-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | Cardinal Health Inc.D-0573-2025 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Documentation & Change Control |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0558-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0574-2025 | Presence of foreign substance: identified as aluminum. | — |
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.