[ 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 |
|---|---|---|---|---|
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0017-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0020-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-22 | Class I | IntegraDose Compounding Services LLCD-0015-2026 | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | Validation & Qualification |
| 2025-10-22 | Class II | Glenmark Pharmaceuticals Inc., USAD-0021-2026 | Failed Impurities/Degradation Specifications | Validation & Qualification |
| 2025-10-22 | Class II | SV Labs Prescott CorporationD-0022-2026 | cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0049-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0063-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0065-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0064-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0057-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0062-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0051-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0054-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0081-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0075-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0076-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0086-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | ACCORD HEALTHCARE, INC.D-0006-2026 | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. | Validation & Qualification |
| 2025-10-15 | Class II | Dr. Reddy's Laboratories, Inc.D-0008-2026 | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. | Validation & Qualification |
| 2025-10-15 | Class II | GenoGenix LLCD-0038-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0045-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0082-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0009-2026 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Risk Management & CAPA |
| 2025-10-15 | Class II | GenoGenix LLCD-0067-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0093-2026 | Lack of Assurance of Sterility | 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.