[ 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.
839 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0209-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0201-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0208-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0204-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0213-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0185-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0183-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0187-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0189-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0194-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0186-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0190-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0195-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0192-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class I | Fresenius Kabi USA, LLCD-0182-2026 | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Environmental Monitoring |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0184-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0193-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0188-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | Medical Products Laboratories, Inc.D-0179-2026 | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Environmental Monitoring |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0196-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0191-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0160-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0161-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | Golden State Medical Supply Inc.D-0158-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0175-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | 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.