[ 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.
3,493 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-07-08 | Class II | Blaine Labs IncD-0697-2026 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Validation & Qualification |
| 2026-07-08 | Class II | Accuray IncorporatedZ-2644-2026 | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. | — |
| 2026-07-08 | Class II | CareFusion 213, LLCD-0643-2026 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | Environmental Monitoring |
| 2026-07-08 | Class II | Boston Scientific CorporationZ-2633-2026 | Potential sterile breach of the pouches in which devices are packaged. | Environmental Monitoring |
| 2026-07-08 | Class I | Insulet CorporationZ-2605-2026 | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. | Risk Management & CAPA |
| 2026-07-08 | Class II | Zimmer Surgical IncZ-2673-2026 | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. | Environmental Monitoring |
| 2026-07-08 | Class II | CareFusion 213, LLCD-0646-2026 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | Environmental Monitoring |
| 2026-07-08 | Class II | Medline Industries, LPZ-2546-2026 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Risk Management & CAPA |
| 2026-07-08 | Class II | Boston Scientific CorporationZ-2637-2026 | Potential sterile breach of the pouches in which devices are packaged. | Environmental Monitoring |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2663-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2655-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Boston Scientific CorporationZ-2635-2026 | Potential sterile breach of the pouches in which devices are packaged. | Environmental Monitoring |
| 2026-07-08 | Class I | Insulet CorporationZ-2604-2026 | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. | Risk Management & CAPA |
| 2026-07-08 | Class II | Medline Industries, LPZ-2613-2026 | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. | Risk Management & CAPA |
| 2026-07-08 | Class II | Asclemed USA Inc.D-0658-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-07-08 | Class I | Baxter Healthcare CorporationZ-2549-2026 | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup. | — |
| 2026-07-01 | Class II | Elevate Oral CareD-0627-2026 | sub potency | Validation & Qualification |
| 2026-07-01 | Class II | Amgen, Inc.D-0614-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | CareFusion 213, LLCD-0622-2026 | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Environmental Monitoring |
| 2026-07-01 | Class II | Amgen, Inc.D-0612-2026 | Presence of Foreign Substance. | — |
| 2026-07-01 | Class II | Annora Pharma Private LimitedD-0626-2026 | Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. | Documentation & Change Control |
| 2026-07-01 | Class I | CareFusion 213, LLCD-0625-2026 | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Environmental Monitoring |
| 2026-07-01 | Class II | Amgen, Inc.D-0613-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0616-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Direct RxD-0617-2026 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Validation & Qualification |
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.