[ 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 |
|---|---|---|---|---|
| 2025-09-17 | Class II | Atlantic Management Resources Ltd.D-0629-2025 | cGMP violations | Risk Management & CAPA |
| 2025-09-17 | Class II | GRACE & FIRE PTY LTDD-0641-2025 | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. | Validation & Qualification |
| 2025-09-17 | Class II | GRACE & FIRE PTY LTDD-0640-2025 | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64. | Validation & Qualification |
| 2025-09-17 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0624-2025 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0633-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Sandoz IncD-0626-2025 | Temperature Abuse | — |
| 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 |
| 2025-09-10 | Class II | Amneal Pharmaceuticals, LLCD-0615-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-10 | Class II | IMMUNOCORE, LLCD-0614-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | Amneal Pharmaceuticals, LLCD-0616-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-10 | Class II | Amneal Pharmaceuticals, LLCD-0619-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-10 | Class III | Boothwyn Pharmacy LLCD-0607-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class I | DermaRite Industries, LLCD-0613-2025 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | Environmental Monitoring |
| 2025-09-10 | Class I | B BRAUN MEDICAL INCD-0628-2025 | Presence of Particulate Matter. | Environmental Monitoring |
| 2025-09-10 | Class I | DermaRite Industries, LLCD-0611-2025 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | Environmental Monitoring |
| 2025-09-10 | Class I | DermaRite Industries, LLCD-0610-2025 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | Environmental Monitoring |
| 2025-09-10 | Class I | DermaRite Industries, LLCD-0612-2025 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | Environmental Monitoring |
| 2025-09-10 | Class II | Amneal Pharmaceuticals, LLCD-0617-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0609-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0606-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class II | Amneal Pharmaceuticals, LLCD-0618-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-10 | Class II | Boothwyn Pharmacy LLCD-0608-2025 | Subpotent Drug | Validation & Qualification |
| 2025-09-10 | Class I | B BRAUN MEDICAL INCD-0627-2025 | Presence of Particulate Matter | Environmental Monitoring |
| 2025-09-03 | Class II | MEDLINE INDUSTRIES, LP - NorthfieldD-0605-2025 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Validation & Qualification |
| 2025-09-03 | Class II | Amerisource Health Services LLCD-0598-2025 | CGMP Deviations: The recalling firm filed for Chapter 11 in September 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 |
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.