[ 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 |
|---|---|---|---|---|
| 2025-10-15 | Class II | Acella Pharmaceuticals, LLCD-0014-2026 | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. | Validation & Qualification |
| 2025-10-15 | Class II | GenoGenix LLCD-0079-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0080-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0040-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0043-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0056-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0087-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0041-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0084-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | RC Outsourcing, LLCD-0003-2026 | Lack of assurance of sterility. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0058-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0072-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | GenoGenix LLCD-0094-2026 | Microbial Contamination of Sterile Products: elevated endotoxin levels | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0070-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0089-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0078-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0047-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | Acuity Specialty Products, Inc.D-0004-2026 | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Risk Management & CAPA |
| 2025-10-15 | Class II | GenoGenix LLCD-0060-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0050-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0012-2026 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Risk Management & CAPA |
| 2025-10-15 | Class II | GenoGenix LLCD-0074-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0091-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0044-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-08 | Class II | Apotex Corp.D-0677-2025 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Environmental Monitoring |
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.