[ 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.
409 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-01-21 | Class II | GOLD STAR DISTRIBUTION INCD-0275-2026 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | Risk Management & CAPA |
| 2026-01-21 | Class II | GOLD STAR DISTRIBUTION INCD-0262-2026 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | Risk Management & CAPA |
| 2026-01-21 | Class II | GOLD STAR DISTRIBUTION INCD-0276-2026 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | Risk Management & CAPA |
| 2026-01-14 | Class II | Signature Formulations, LLCD-0253-2026 | cGMP Deviations | Risk Management & CAPA |
| 2026-01-14 | Class II | Signature Formulations, LLCD-0252-2026 | 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-0212-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0211-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0210-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0202-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0203-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0205-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Park Avenue CompoundingD-0200-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0207-2026 | 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-0206-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0213-2026 | cGMP deviations | Risk Management & CAPA |
| 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 |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0195-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0193-2026 | 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-0192-2026 | 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-0196-2026 | CGMP Deviations | 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.