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.
Cairo Bakery Pita Pocket Bread is recalled for containing undeclared milk. Packages with code 01/18 distributed in California may be affected.
COREPACK MANUFACTURING INC is recalling White Maeng da kratom powder due to possible Salmonella contamination. The affected product was distributed throughout the United States.
Bazzini LLC is recalling NuGo Dark Chocolate Chip bars because they contain undeclared milk, which poses a health risk to consumers with milk allergies.
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Bazzini LLC is recalling NuGo Dark Chocolate Pretzel bars because they contain undeclared milk. Consumers with milk allergies should not consume the affected product.
Mutual Trading Company is recalling ANKIMOBO brand prepared monkfish liver (UPC: 72546611224) because the product contains an undeclared milk allergen. The product poses a risk to consumers with milk allergies.
La Fiesta PAN RAYADO Bread Crumbs are being recalled for undeclared sesame, an allergen not listed on the label. The recall affects 2,200 cases distributed nationwide.
Atkinson Milling Company is recalling Atkinson's No Onions Plain Hushpuppies due to undeclared milk on the label. Consumers with milk allergies who consume this product risk allergic reaction.
Atkinson Milling Company is recalling Atkinson's Hushpuppies with Onions due to undeclared milk. The product was not labeled as containing milk, posing a risk to consumers with milk allergies.
La Fiesta Food Products is recalling seasoned bread crumbs because they contain undeclared sesame, an allergen not listed on the label. The product was distributed nationwide.
VidaSlim dietary supplements and beverages are being recalled due to toxic yellow oleander contamination. The FDA Class I recall affects 760 units distributed nationwide.
Bazzini LLC is recalling NuGo Dark Pretzel/Chocolate Chip Multipack bars due to undeclared milk. The product poses a risk to consumers with milk allergies.
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
FGF, LLC is recalling flavored sour cream cake donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2.0 million cases distributed in the US and Canada are affected.
Oxoid Limited is recalling 1,406 units of Lev5 Levofloxacin susceptibility discs because packaging may contain Norfloxacin discs instead, which could affect laboratory test results.
FGF, LLC is recalling 2,017,614 cases of yeast ring donuts nationwide due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024.
Dierbergs Markets recalls 298 packages of Mac & Cheese due to labeling errors that fail to disclose wheat allergens. The product was distributed to Missouri and Illinois retailers with a use-by date of 1/9/2025.
FGF, LLC is recalling chocolate-coated donut rings nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected. No illnesses have been reported.
FGF, LLC is recalling 2,017,614 cases of frozen chocolate hex donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the affected product.
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.
FGF LLC is recalling Persian Donut item 8201808 nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard it or return it to the retailer.
FGF, LLC is recalling over 2 million cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.
GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.
The FDA has recalled Greenwise Organic Pecan Halves (8-ounce bags) due to undeclared walnuts, a major allergen. The affected product was distributed in eight southeastern states.