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.
Cardinal Health is recalling 661,560 tracheostomy kits because they were manufactured with components that were subsequently recalled by another manufacturer.
Neptune's Fix Tianeptine Tablets are being recalled because the product contains tianeptine, a substance not approved by the FDA for any medical use. The recall affects 4,932 boxes distributed nationwide.
Insight Pharmaceuticals is recalling TING 1% Tolnaftate Athlete's Foot Spray due to benzene contamination. The recall affects approximately 59,644 cans distributed nationwide.
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
Windstone Medical Packaging is recalling Aligned Medical Solutions Closure Kits due to inability to guarantee sterility of included saline. This FDA Class I recall affects 475 units distributed in Florida, Illinois, and California.
Cardinal Health is recalling 36,300 Foley urinary drainage convenience kits due to components that were subsequently recalled by supplier Nurse Assist.
Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.
Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.
Sustain Herbal Dietary Supplement is being recalled nationwide for containing undeclared tadalafil, a pharmaceutical ingredient. The product was marketed as a dietary supplement but contains an unapproved drug.
Dover Foley catheter kits and silicone drain trays manufactured with subsequently recalled components were distributed to 924 units across the US, EMEA, Japan, and Latin America.
Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.
Hale and Hearty Soups is recalling Tomato Basil and Rice soup (UPC 635508547872) due to undeclared soy allergen. Consumers with soy allergies should not consume this product.
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
Mennel Milling Company is recalling bulk product 2-00007-0000 due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
Micro Labs Limited is recalling 24,768 bottles of Clobazam 10mg tablets nationwide due to out-of-specification residual solvents. Patients should contact their healthcare provider for guidance.
Mennel Milling Company is recalling pizza flour due to potential contamination with metal, wood, gasket material, and sifter balls. Approximately 2.6 million pounds were distributed across Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
Philips Azurion 5 X-ray systems with Certeray generators may experience power loss due to a potential short circuit in the power inverter board, potentially delaying or interrupting medical procedures.
A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
Mennel Milling Company is recalling bulk bread flour due to potential contamination with metal, wood, gasket material, and sifter balls. The flour was distributed to bakeries and food manufacturers in six states.
Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.
Country Corner Dairy is recalling Yellow Cheddar Cheese due to lack of proper pasteurization. The product was distributed in Maryland and Virginia and may pose a food safety risk.
Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.
Bestco LLC is recalling Equate Cherry Cough Drops nationwide due to potential glass and silicone particulates from manufacturing deviations. Affected products are 30-drop and 160-drop bags expiring December 31, 2026.
Henry Schein Inc. and Glove Club HSI Gloves Inc. are recalling 1,099 vials of Adrenalin (Epinephrine) Injection because the expiration date on the repack pouch label is incorrect. The product was distributed nationwide.