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.
Quaker Oats Co. is recalling Quaker Oatmeal Squares Brown Sugar in multiple sizes due to potential Salmonella contamination. Affected products have Best Before dates of Aug-02-24 or earlier and were distributed nationally and internationally.
EMD Millipore has recalled Schiff Reagent Hotchkiss-McManus (lots 3094 and 3096) because units appear pink instead of colorless. Laboratories should discontinue use of affected units distributed to US states and Canada.
Ancient Formulas' Healthprint Vitamin D3 5000 supplement contains less Vitamin D than claimed and has incorrect daily value labeling. The recall affects 111 bottles distributed in Florida.
Parker Laboratories is recalling Tensive Conductive Adhesive Gel due to five complaints regarding incorrect viscosity. The affected product was distributed across multiple US states and internationally.
Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.
Seatex LLC is recalling PROBLEND Hand Sanitizer (Lot 266029) nationwide due to manufacturing deficiencies identified during FDA inspection.
Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer due to manufacturing practice deviations identified during FDA inspection. The recall affects products distributed nationwide in the US and Puerto Rico.
Seatex LLC is recalling 1,450 cases of PROBLEND Antibacterial Foaming Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations discovered at its manufacturing facility. The recall affects product distributed nationwide in the United States and Puerto Rico.
Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.
Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.
A hand sanitizer distributed to 7-Eleven gas stations nationwide is being recalled due to manufacturing deficiencies identified during an FDA inspection. The affected product is lot 251176, distributed in the United States and Puerto Rico.
GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.
Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by 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.
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.
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.
Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.
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.
Neptune's Fix Tianeptine Elixir is recalled nationwide for containing tianeptine, an FDA-unapproved substance. The product was marketed without required FDA approval.
Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.
Windstone Medical Packaging recalled 128 surgical eye kits because the included saline cannot be guaranteed sterile, risking post-operative infection.
SCHWINNNG Herbal Dietary Supplement (Lot #2108, exp. 10/31/2024) is recalled nationwide because it contains undeclared nortadalafil, an active pharmaceutical ingredient used for male sexual enhancement. The FDA classified this as an unapproved drug.
Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.