[ 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 |
|---|---|---|---|---|
| 2026-05-13 | Class I | Givaudan Flavors CorpH-0837-2026 | Product has the potential to be contaminated with Salmonella. | Environmental Monitoring |
| 2026-05-13 | Class II | Wehah FarmsH-0767-2026 | Potential contamination with foreign materials. | Environmental Monitoring |
| 2026-05-13 | Class II | Horizon Organic Dairy, LLCH-0711-2026 | Package integrity compromised. | Documentation & Change Control |
| 2026-05-13 | Class I | Raw Farm LLCH-0764-2026 | Multi-state outbreak of E. coli O157:H7. | Environmental Monitoring |
| 2026-05-13 | Class II | Silver Moon LP dba Loard's Ice CreamH-0745-2026 | Undeclared Milk, Soy, Red #40. | Documentation & Change Control |
| 2026-05-13 | Class I | Raw Farm LLCH-0765-2026 | Multi-state outbreak of E. coli O157:H7. | Environmental Monitoring |
| 2026-05-13 | Class I | American Contract Systems IncZ-1981-2026 | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism. | — |
| 2026-05-13 | Class II | Katalyst Surgical, LLCZ-2070-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class II | CareFusion 213, LLCD-0517-2026 | Lack of assurance of Sterility: potential product contamination | Environmental Monitoring |
| 2026-05-13 | Class II | Walker Honey CoH-0704-2026 | Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. | — |
| 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 | 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 | Silver Moon LP dba Loard's Ice CreamH-0744-2026 | Undeclared Milk, Pecans. | Documentation & Change Control |
| 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 | Walker Honey CoH-0709-2026 | Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. | — |
| 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 | 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.