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.
Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.
Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.
Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.
Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.
Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.
Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.
Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.
Waco Bottling LLC is recalling TriyBrewed Coffee Concentrate 6oz bottles due to missing ingredient statement and nutrition label. Consumers cannot verify product contents or nutritional information.
Danisco USA Inc. is recalling GS 1134 Kreme WIP, a food ingredient product, due to potential Salmonella contamination affecting multiple U.S. states, Canada, and Mexico.
Danisco USA Inc. is recalling Germantown Gard (A) Preservative due to potential Salmonella contamination. The recall affects 21,000 kg distributed across the US, Canada, and Mexico.
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
Danisco USA Inc. has issued a recall of Grindsted ASC 2354 Stabilizer and Emulsifier System for potential Salmonella contamination. The product is distributed to multiple US states, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Yogurt 7133 Stabilizer System due to potential Salmonella contamination. The affected ingredient was distributed to multiple U.S. states, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Creamer 2395 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed across the US, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Hi-Dress CDS 1880 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed to facilities across multiple US states, Canada, and Mexico.
Multiple brands of yogurt pretzels are being recalled due to potential Salmonella contamination. Affected products were distributed in California and Washington.
The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.
Danisco USA Inc. is recalling Grindsted Iced Coffee 6752 Stabilizer System in 50 lb bags due to potential Salmonella contamination. The recall affects product distributed across the US, Canada, and Mexico.
Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.
Danisco USA Inc. recalls Grindsted Turkey Hill 1512 NF NSA Stabilizer and Emulsifier System (10 lot numbers) due to potential Salmonella contamination. The 2,270-pound product was distributed to 28 US states, Canada, and Mexico.
Hormel Foods is recalling Planters Deluxe Lightly Salted Mixed Nuts (8.75 oz) due to possible Listeria monocytogenes contamination. The recall affects 6,804 cans distributed to five southeastern states.
Danisco USA Inc. is recalling Grindsted WCS 1265 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed across the US, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted SSD 6018 Stabilizer System due to potential Salmonella contamination. The product has been distributed to customers in the United States, Canada, and Mexico.
Danisco USA Inc. has recalled Grindsted SSD 6242 Stabilizer System due to potential Salmonella contamination. The recall affects 884.52 kg of product distributed to the United States, Canada, and Mexico.
Hormel Foods is recalling PLANTERS Honey Roasted Peanuts 4oz packages due to possible Listeria monocytogenes contamination. Approximately 15,132 packages were distributed to retailers in FL, GA, AL, NC, and SC.