[ 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.
1,235 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-22 | Class II | PAYLESS COMPOUNDERS, LLCD-0471-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-22 | Class II | Owen Biosciences Inc.D-0452-2026 | Chemical contamination: Presence of benzene | Environmental Monitoring |
| 2026-04-22 | Class II | Owen Biosciences Inc.D-0455-2026 | Chemical contamination: Presence of benzene | Environmental Monitoring |
| 2026-04-22 | Class II | Huons Co., Ltd.D-0532-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1818-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Huons Co., Ltd.D-0530-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1816-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Medline Industries, LPZ-1824-2026 | On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1819-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Remel, IncZ-1806-2026 | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. | Environmental Monitoring |
| 2026-04-22 | Class II | Huons Co., Ltd.D-0531-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-22 | Class I | Insulet CorporationZ-1797-2026 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the de | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1820-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-22 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-1817-2026 | Increased rate of out-of-specification endotoxin results. | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0434-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0429-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Preferred Pharmaceuticals, Inc.D-0443-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0435-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Cipla USA, Inc.D-0423-2026 | Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0432-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fagron Compounding ServicesD-0440-2026 | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0428-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0426-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0430-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0427-2026 | 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.