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 Healthcare is recalling Fluticasone Propionate Nasal Spray (50MCG per spray) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Nationwide distribution affected.
Cardinal Healthcare is recalling Meloxicam 15 mg tablets nationwide due to exposure to temperatures outside labeled storage conditions. No adverse events have been reported.
ARMOUR THYROID 120 mg tablets in batch W05543 are being recalled nationwide due to exposure to temperatures outside the labeled storage conditions. No illnesses or injuries have been reported.
Cardinal Healthcare is recalling Terconazole Vaginal Suppositories (batch 1014228A) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.
Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.
Ricola Cherry Honey Herb Throat Drops are recalled because products in batch 2000058693 were exposed to temperatures outside the labeled storage conditions during distribution. The Class II recall affects nationwide shipments.
Cardinal Healthcare recalls albuterol sulfate inhalation aerosol batch MY7E nationwide due to exposure to temperatures outside labeled storage conditions. The precautionary recall affects 2 cartons.
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
Jardiance 25 mg tablets distributed nationwide were recalled due to CGMP deviations where products were exposed to temperatures outside the labeled storage conditions. The recall affects batch D41919.
Trader Joe's Fresh Cut Fruit Cantaloupe Chunks are being recalled due to potential Salmonella contamination. The product was distributed in Alabama, Georgia, Florida, North Carolina, and South Carolina.
Renaissance Food Group has recalled 67 units of 32 oz Mixed Fruit Bowls due to potential Salmonella contamination. The affected product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
TGD Cuts, LLC is recalling a packaged fruit tray due to potential Salmonella contamination. Affected products were distributed in PA, NJ, MD, WV, SC, VA, DE, NC, and NY.
Renaissance Food Group is recalling Mixed Melon with Taijin due to potential Salmonella contamination. The product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
Renaissance Food Group is recalling Cantaloupe Chunks with Tajin due to potential Salmonella contamination. The product was distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
Renaissance Food Group is recalling Large Fruit Trays (73 oz) distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina due to potential Salmonella contamination.
Nurse Assist, LLC is recalling sterile water and saline bottles across multiple brands due to potential lack of sterility assurance. The products could be nonsterile and may cause infection.
Raw Seafoods Inc. is recalling frozen, lightly seasoned salmon burgers nationwide due to undeclared sesame seeds and milk, which pose serious allergic reaction risk to sensitive consumers.
Renaissance Food Group is recalling Fruit Medley products in 9 oz and 18 oz sizes due to Salmonella contamination. The affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
HMC Farms White Nectarines 2lb Gusset Bags are recalled due to potential contamination with Listeria monocytogenes. The affected product was distributed across the United States and internationally.
THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.
TGD Cuts, LLC is recalling MIX FRUIT ALOHA BOWL due to potential Salmonella contamination. Affected products were distributed in PA, NJ, MD, WV, SC, VA, DE, NC, and NY.
Manischewitz Magic Max's Dark Chocolate Coins are recalled due to undeclared milk from mispackaging. The product was distributed to retailers in multiple states and may affect consumers with milk allergies.
TGD Cuts, LLC is recalling Mixed Fruit Cube 1/2" products due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.
TGD Cuts, LLC is recalling Mix Fruit Luau Bowl products due to potential Salmonella contamination. Affected units were distributed in eight states with use-by dates from November 2-23, 2023.
Renaissance Food Group recalls Trader Joe's Fresh Cut Fruit Fruitful Medley due to potential Salmonella contamination. The product was distributed to customers in Alabama, Georgia, Florida, North Carolina, and South Carolina.