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 is recalling reFORM dietary supplement because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Great Value Kettle Cooked Lightly Salted Potato Chips from an Ohio distribution center were packaged with incorrect labeling that fails to declare milk protein, posing a risk to consumers with milk allergies.
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.
TruVision Health is recalling TruControl 7 Day Trifold dietary supplement (lot WKW72353) because it contains DMHA and hordenine, which the FDA determined are not acceptable dietary supplement ingredients.
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 oxyTOCIN with Lactated Ringer's injection (14,362 bags) nationwide due to FDA inspection findings that questioned sterility assurance.
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 its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.
Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.
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 recalls 7,632 bags of vancomycin injectable (NDC 71285-6078-1) nationwide due to FDA-identified sterility assurance deficiency.
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 recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
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.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.
Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.
Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services recalled 2,146 bags of potassium phosphate with sodium chloride solution nationwide because FDA inspection raised concerns about whether the sterile products met required sterility standards.
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
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.
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Reperfusate 4:1 due to lack of sterility assurance identified during an FDA inspection. The recall affects 338 bags distributed nationwide.
Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.
Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Cardioplegia Solution due to lack of assurance of sterility following an FDA inspection. The product was distributed nationwide.