Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
TruVision Health LLC recalls TruBoost 7 Day Experience Kit due to the presence of DMHA and/or hordenine, which the FDA determined are not acceptable dietary ingredients.
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.
Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.
Country Cookie LLC is recalling molasses cookies due to undeclared milk allergen on the label. Consumers with milk allergies who consume this product face serious allergic reactions.
Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bars are being recalled due to possible presence of metal. The recall affects approximately 22,290 boxes distributed nationwide.
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.
Country Cookie Pumpkin Bars are being recalled because the product label fails to declare milk as an ingredient, posing a risk to consumers with milk allergies. Products with 'Baked On' dates through April 17, 2023, distributed in Missouri and Kansas are affected.
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
Central Admixture Pharmacy Services is recalling 3,999 units of diphenhydramine injectable due to sterility assurance concerns identified during an FDA inspection. No illnesses have been reported.
Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.
Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.
Country Cookie LLC is recalling Country Cookie Peanut Butter Chocolate Chip cookies sold in Missouri and Kansas retailers because milk is not declared on the label despite being present in the product.
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.
Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile assurance.
Central Admixture Pharmacy Services is recalling oxyTOCIN with Lactated Ringer's injection (14,362 bags) nationwide due to FDA inspection findings that questioned sterility assurance.
Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.
Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.