[ 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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-05-20 | Class II | FINESALER LLCH-0773-2026 | Product may contain foreign objects, specifically glass. | Environmental Monitoring |
| 2026-05-20 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2170-2026 | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. | — |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2177-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0768-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Ocinet, Inc.H-0780-2026 | Undeclared allergen ingredient (fish) | Documentation & Change Control |
| 2026-05-20 | Class II | Raja Foods and Vegetables Inc.H-0777-2026 | Contains undeclared FD&C Yellow 6 | Documentation & Change Control |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0769-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0771-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | WE R NUTSH-0775-2026 | Contains undeclared allergens (cashews, milk, and soy). | Documentation & Change Control |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0770-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 2026-05-20 | Class II | Oasis Medical, Inc.D-0525-2026 | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. | Environmental Monitoring |
| 2026-05-20 | Class II | Raja Foods and Vegetables Inc.H-0778-2026 | Contains undeclared Blue 1 | Documentation & Change Control |
| 2026-05-13 | Class II | Fresenius Medical Care Holdings, Inc.D-0512-2026 | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Environmental Monitoring |
| 2026-05-13 | Class II | Ajanta Pharma Ltd.D-0515-2026 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Validation & Qualification |
| 2026-05-13 | Class II | Teva Pharmaceuticals USA, IncD-0519-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-05-13 | Class II | Fresenius Medical Care Holdings, Inc.D-0513-2026 | Lack of Assurance of Sterility: Potential leaks from perforations in bags. | Environmental Monitoring |
| 2026-05-13 | Class I | B BRAUN MEDICAL INCD-0540-2026 | Presence of Particulate Matter. | Environmental Monitoring |
| 2026-05-13 | Class II | Breckenridge Pharmaceutical, Inc.D-0522-2026 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Validation & Qualification |
| 2026-05-13 | Class III | Unichem Pharmaceuticals USA Inc.D-0511-2026 | Subpotent drug | Validation & Qualification |
| 2026-05-13 | Class II | Ajanta Pharma Ltd.D-0516-2026 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Validation & Qualification |
| 2026-05-13 | Class II | JB Chemicals and Pharmaceuticals LtdD-0520-2026 | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test | Validation & Qualification |
| 2026-05-13 | Class II | CareFusion 213, LLCD-0518-2026 | Lack of assurance of Sterility: potential product contamination | Environmental Monitoring |
| 2026-05-13 | Class II | Central Admixture Pharmacy Services, Inc (CAPS) Los AngelesD-0524-2026 | Incorrect Product Formulation: product did not contain insulin as listed in the label. | Documentation & Change Control |
| 2026-05-13 | Class II | Ajanta Pharma Ltd.D-0514-2026 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Validation & Qualification |
| 2026-05-13 | Class II | Acella Pharmaceuticals, LLCD-0523-2026 | Chemical contamination; presence of lead and lithium above specification | 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.