[ 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 |
|---|---|---|---|---|
| 2025-10-08 | Class II | Zydus Pharmaceuticals (USA) IncD-0001-2026 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Validation & Qualification |
| 2025-10-08 | Class II | Zydus Pharmaceuticals (USA) IncD-0002-2026 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Validation & Qualification |
| 2025-10-08 | Class II | Amerisource Health Services LLCD-0675-2025 | Failed Dissolution Specifications. | Validation & Qualification |
| 2025-10-08 | Class II | Apotex Corp.D-0676-2025 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Environmental Monitoring |
| 2025-10-01 | Class III | Granules Pharmaceuticals Inc.D-0670-2025 | Failed Impurities/Degradation Specifications: | Validation & Qualification |
| 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 | Private Label Skin Care Inc.D-0668-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-10-01 | Class III | Medline Industries, LPD-0674-2025 | Subpotent drug | Validation & Qualification |
| 2025-10-01 | Class III | Consumer Product Partners, LLCD-0661-2025 | Cross Contamination with Other Products. | Environmental Monitoring |
| 2025-10-01 | Class III | Consumer Product Partners, LLCD-0660-2025 | Cross Contamination with Other Products. | Environmental Monitoring |
| 2025-10-01 | Class II | Private Label Skin Care Inc.D-0666-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-10-01 | Class II | Private Label Skin Care Inc.D-0667-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-10-01 | Class II | Private Label Skin Care Inc.D-0664-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-10-01 | Class II | Private Label Skin Care Inc.D-0665-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-10-01 | Class III | Granules Pharmaceuticals Inc.D-0671-2025 | Failed Impurities/Degradation Specifications: | Validation & Qualification |
| 2025-10-01 | Class III | Granules Pharmaceuticals Inc.D-0669-2025 | Failed Impurities/Degradation Specifications: | Validation & Qualification |
| 2025-10-01 | Class III | Granules Pharmaceuticals Inc.D-0672-2025 | Failed Impurities/Degradation Specifications: | Validation & Qualification |
| 2025-10-01 | Class III | Granules Pharmaceuticals Inc.D-0673-2025 | Failed Impurities/Degradation Specifications: | Validation & Qualification |
| 2025-10-01 | Class II | YANGZHOU YULOU PAPER PRODUCTS CO., LTDD-0659-2025 | cGMP Deviations | Risk Management & CAPA |
| 2025-10-01 | Class II | Private Label Skin Care Inc.D-0663-2025 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Environmental Monitoring |
| 2025-09-24 | Class II | Zydus Pharmaceuticals (USA) IncD-0657-2025 | Failed Impurity/Degradation Specifications | Validation & Qualification |
| 2025-09-24 | Class II | B BRAUN MEDICAL INCD-0653-2025 | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Environmental Monitoring |
| 2025-09-24 | Class II | Zydus Pharmaceuticals (USA) IncD-0656-2025 | Failed Impurity/Degradation Specifications | Validation & Qualification |
| 2025-09-24 | Class II | B BRAUN MEDICAL INCD-0652-2025 | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Environmental Monitoring |
| 2025-09-24 | Class II | Fagron Compounding ServicesD-0646-2025 | 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.