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.
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.
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.
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.
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.
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.
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, 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 is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
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.
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
Country Cookie LLC is recalling M&M cookies and mini cups distributed in Missouri and Kansas because the label does not declare milk as an allergen. Consumers allergic to milk should discard the recalled products.
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.
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 recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.
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 recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
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.
GH Foods LLC is recalling The Traveler's Best Ham & Swiss on Pretzel Roll sandwiches due to undeclared sesame seeds. Sesame is a major allergen; consumers with sesame allergies face serious health risks.
TruVision Health LLC is recalling TruBoost Drink - Citrine Spark because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients. Consumers should not consume the product.
Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.
Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.
Litehouse Inc. is recalling Simple Truth Plant Based Ranch Dressing 12 oz bottles (UPC 01110609779) because bottles labeled as ranch dressing contain Caesar dressing instead. Affected product has lot code 1713802052623 and was distributed in Indiana.
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.