[ 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 I | Medline Industries, LPZ-2141-2026 | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Environmental Monitoring |
| 2026-05-20 | Class II | Stryker Sustainability SolutionsZ-2191-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class I | Omnicell, Inc.Z-2047-2026 | Potential for mislabeled syringe produced by the i.v.STATION device. | Documentation & Change Control |
| 2026-05-20 | Class II | Hologic, IncZ-2167-2026 | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | — |
| 2026-05-20 | Class II | Prospector Popcorn, LLCH-0779-2026 | Products contain undeclared soy, specifically soy lecithin. | Documentation & Change Control |
| 2026-05-20 | Class I | Sugar Foods LLCH-0781-2026 | Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella. | Environmental Monitoring |
| 2026-05-20 | Class II | Ferris Coffee and Nut Company, Inc.H-0774-2026 | Undeclared allergens (wheat and soy). | Documentation & Change Control |
| 2026-05-20 | Class I | Pure Ground Ingredients, Inc.H-0853-2026 | Product has the potential to be contaminated with Salmonella. | Environmental Monitoring |
| 2026-05-20 | Class II | Dakota Honey CompanyH-0772-2026 | Foreign object (stainless steel dust/flakes or shreds of plastic) | Environmental Monitoring |
| 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 | Stryker Sustainability SolutionsZ-2197-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 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 | Stryker Sustainability SolutionsZ-2185-2026 | Incomplete seals on sterile product | Environmental Monitoring |
| 2026-05-20 | Class II | GE Medical Systems, LLCZ-2149-2026 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems. | Data Integrity |
| 2026-05-20 | Class II | Ascend Laboratories, LLCD-0547-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2026-05-20 | Class II | ENDO USA, Inc.D-0527-2026 | Crystallization; identified as Buprenorphine free base | — |
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.