[ 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 |
|---|---|---|---|---|
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0191-2026 | 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-0185-2026 | 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 | CA BOTANA International, Inc.D-0194-2026 | 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-0184-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-03 | Class II | CA BOTANA International, Inc.D-0183-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-11-26 | Class II | Park Avenue CompoundingD-0178-2026 | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. | Risk Management & CAPA |
| 2025-10-22 | Class II | Amerisource Health Services LLCD-0027-2026 | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Risk Management & CAPA |
| 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 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0013-2026 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Risk Management & CAPA |
| 2025-10-15 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0010-2026 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Risk Management & CAPA |
| 2025-10-15 | Class II | Acuity Specialty Products, Inc.D-0005-2026 | 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 | 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 | 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 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0011-2026 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | Risk Management & CAPA |
| 2025-10-01 | Class II | Glenmark Pharmaceuticals Inc., USAD-0662-2025 | CGMP Deviations: Market complaints received for gritty texture (grainy) | Risk Management & CAPA |
| 2025-10-01 | Class II | YANGZHOU YULOU PAPER PRODUCTS CO., LTDD-0659-2025 | cGMP Deviations | Risk Management & CAPA |
| 2025-10-01 | Class III | SUNGAL INCH-0636-2025 | Cyclamate adulteration | Risk Management & CAPA |
| 2025-09-24 | Class II | Sandoz IncD-0651-2025 | cGMP deviations: Temperature excursion during transportation. | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0638-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0634-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0637-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0639-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | 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.