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.
DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.
WHH A&D Calcium Milk Drink recalled due to undeclared milk on the ingredient label. The recall affects 12,000 units distributed in California.
Daiso California Warehouse is recalling Meito Milk Cocoa (12gX5P, UPC 4902757444709) because coconut allergen is not declared on the label. Consumers with coconut allergies should discontinue use and return the product.
Igarashiseimen Kitakata Spicy Umakara Ramen is being recalled because coconut allergen is not declared on the label. Consumers with coconut allergies should not consume this product.
Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.
DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.
Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal patches due to a defective delivery system that is out of specification for shear. Affected lots are Lot 91956 (6/2023) and Lot 92475 (7/2023), distributed nationwide.
DePuy Orthopaedics is recalling 7 units of the Attune Revision Tibial Insert that received excess gamma radiation during manufacturing, which may degrade implant material properties.
MEITO Alphabet Chocolate 50g packages sold in multiple U.S. states and Canada were distributed with undeclared coconut allergen. Consumers with coconut allergies should not consume this product.
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
Onishi Foods Alpha Rice Matsutake Mushroom Rice is being recalled because the label does not declare coconut, a major allergen. The recall affects 733 units distributed in multiple US states and Canada.
Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.
DePuy Orthopaedics is recalling 7 units of the Attune Revision Limb Preservation System Tibial Insert (Lot JP9022) that received higher than specified gamma radiation doses. The over-irradiation may cause changes to implant material properties.
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
Raystation radiation therapy planning software may not correctly export collimator angle settings when using the DICOM export function. In exported files, the collimator angle may be replaced with zero regardless of the user's selection.
Sprouts Farmers Market is recalling Saltine Crackers Sea Salt Tops due to potential peanut contamination. Approximately 1,050 cases were distributed in Arizona, California, and Georgia.
DAISO CALIFORNIA WAREHOUSE is recalling Kurata Menzo Meatfree Tonkotsu Ramen Dry due to undeclared coconut on the label. Consumers with coconut allergies who consume this product may experience allergic reactions.
DAISO CALIFORNIA WAREHOUSE is recalling 150YEN HIZATSUKI Soft rice crackers because the product contains coconut that was not declared on the label. Consumers with coconut allergies should not consume this product.
DG Health Sugar Free Daily Fiber is recalled for missing a required phenylalanine warning label. People with phenylketonuria (PKU) require this warning to safely use the product.
CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.
Haiyue Food Nutritional Preserved Vegetable is recalled because it contains cyclamate, an unauthorized food additive in the United States. The FDA Class III recall affects 55 boxes distributed in New York, North Carolina, Florida, and Indiana.
Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.
Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.
DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.
Fresh Creative Cuisine Caprese Baguette products distributed January 24-30, 2023, are recalled for potential Listeria monocytogenes contamination across multiple states and Washington D.C.