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.
Berner Foods Inc. is recalling Kirkland Signature Colombian Cold Brew Coffee due to metal contamination in 231,071 cases distributed across 13 states. Consumers should stop using affected products.
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.
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.
Kinjo Seika Potato Yokan confection is being recalled because coconut, a major allergen, was not declared on the label. Consumers with coconut allergies should not consume this product.
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.
Noven Pharmaceuticals recalls Daytrana (methylphenidate) 30 mg transdermal patches nationwide due to defective delivery system components that fail shear specifications. Patients should contact their healthcare provider regarding medication alternatives.
Russell Stover Sugar Free Peanut Butter Cups are being recalled for undeclared tree nuts (pecans) on the outer packaging. The mislabeling poses a risk to consumers with tree nut allergies.
Onishi Foods Alpha Rice Mushroom Rice is recalled due to undeclared coconut allergen on the label. Consumers with coconut allergies should not consume this product.
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.
Bruttles Gourmet Candies Butter Toffee products lack allergen warnings for milk and soy. Consumers with allergies should not consume these products.
Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up affecting 69,375 bottles distributed nationwide.
CareFusion recalls 7,914 units of BD Pyxis automated medication dispensing systems after firmware was inadvertently downgraded during installation, potentially causing drawer failures and medication delivery delays.
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.
BA Sports Nutrition is recalling BODYARMOR SportWater due to potential plastic pieces in the product. The recall affects approximately 21 million bottles distributed across 11 states.
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.
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.
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.
WHH A&D Calcium Milk Drink recalled due to undeclared milk on the ingredient label. The recall affects 12,000 units distributed in California.
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 Daytrana methylphenidate transdermal patches for a defective delivery system that fails to meet shear specifications. The recall affects specific lots distributed nationwide.