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.
Arjohuntleigh Magog, Inc. is recalling certain Arjo Portable Scale Adaptors due to straps with potential to detach. Three units were distributed in Ohio and New York.
Central Admixture Pharmacy Services is recalling 2,186 bags of oxytocin intravenous admixture nationwide due to lack of sterility assurance following an FDA inspection.
Country Cookie LLC recalled Country Cookie Carrot Cake products because the packaging fails to declare milk as an allergen. The recall affects clamshell packages distributed to retailers in Missouri and Kansas.
Country Cookie LLC is recalling Country Cookie Sugar Cookies because the allergen statement does not declare milk, a common allergen. Affected products were distributed to retailers in Missouri and Kansas.
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.
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.
Country Cookie LLC is recalling Country Cookie No Bake cookies and Country Cookie Cup of Mini Cookies No Bake sold in MO and KS because the allergen statement fails to declare milk.
Central Admixture Pharmacy Services is recalling 255 bags of Cardioplegia Solution after FDA inspection questioned its sterility assurance. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling 1,735 bags of phenylephrine injectable nationwide after FDA inspection raised concerns about product sterility assurance. No illnesses have been reported.
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 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 Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.
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.
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.
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.
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.
Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Central Admixture Pharmacy Services recalls 5,627 bags of diphenhydramine 25 mg intravenous solution nationwide. An FDA inspection called into question the sterility of the products intended to be sterile.
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.
Country Cookie LLC is recalling Oatmeal Raisin Cookies because the label does not declare milk allergen. The recall affects cookies distributed to retailers in Missouri and Kansas.
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.
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 is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.