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.
Con Yeager Spice Company is recalling Trail Bologna Meat Processing Kits because they contain undeclared wheat and soy allergens. Affected consumers with allergies should not consume the product.
4 Earth Farms Stir Fry Medley vegetables are being recalled due to potential E. coli O121:H19 contamination. The affected product was distributed to retailers across multiple states; consumers should not eat the product and should discard it.
Sysco Corporation is recalling whole and cut cucumbers distributed in the Midwest and Canada due to potential Salmonella contamination.
4 Earth Farms is recalling Vegetable Medley due to potential contamination with E. coli O121:H19. Approximately 6,036 cases were distributed across multiple states.
4 Earth Farms is recalling Organic Vegetable Medley packages due to potential contamination with E. coli O121:H19. The affected products were distributed across multiple states to distribution centers and retailers.
4 Earth Farms is recalling its 32-oz Vegetable Medley product distributed by Walmart due to potential contamination with E. coli O121:H19. The product was distributed to retail locations across multiple states.
4Earth Farms is recalling Organic Broccoli Slaw for potential E. coli O121:H19 contamination. Products were distributed to retail and distribution centers across multiple states.
Walmart is recalling Marketside Fresh Cut Cucumber Slices sold in Texas due to potential Salmonella contamination. Consumers should not eat this product and should return or dispose of it.
4Earth Farms is recalling 6,036 cases of organic carrots distributed across multiple states due to potential E. coli O121:H19 contamination.
4 Earth Farms is recalling Organic Vegetable Medley (Broccoli, Carrots & Cauliflower) sold at Walmart due to potential contamination with E. coli O121:H19. The recall affects 6,036 cases distributed across multiple states.
F&S Produce West LLC is recalling Mediterranean Party Trays (sell-by dates 11/27/2024–12/11/2024) due to potential Salmonella contamination in the tzatziki sauce. The product was distributed to 187 retail locations in seven western states.
Viatris Inc. is recalling 19,549 bottles of Levothyroxine Sodium 175 mcg tablets nationwide due to potency failures. Some tablets contain excessive active ingredient while others contain insufficient amounts.
Giant Eagle churned Butter Pecan Reduced Fat ice cream is being recalled because it contains undeclared soy (soy lecithin), posing a risk to consumers with soy allergies.
Super Brand Dried Cinnamon Powder (4 oz) distributed across nine states is being recalled due to elevated lead levels. Consumers should discard purchased containers.
Mckesson Medical-Surgical Inc. is recalling HYLENEX RECOMBINANT (hyaluronidase) injection due to cGMP deviations involving a temperature excursion during storage, which may have compromised drug potency.
Viatris Inc. is recalling Levothyroxine Sodium 200 mcg tablets nationwide due to potency failures—some tablets are superpotent while others are subpotent. Affected lots expire July 2025; patients should contact their healthcare provider.
Micro-X Ltd. is recalling five MICRO-X Rover Mobile X-ray Systems due to a timing defect that prevents adequate X-ray exposures. The 4 millisecond exposure time does not allow sufficient tolerance for diagnostic-quality imaging.
The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.
Mylan Institutional is recalling Levothyroxine Sodium tablets nationwide due to subpotent and superpotent units. Patients taking affected tablets may receive incorrect doses of this thyroid medication.
Mylan Institutional recalls levothyroxine sodium tablets (lot 3115707) due to subpotent and superpotent tablets. The product was distributed nationwide. Consult your healthcare provider.
Mylan Institutional is recalling 2,835 cartons of Levothyroxine Sodium 100 mcg tablets nationwide due to potency deviations—some tablets may be underdosed while others may be overdosed.
Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.
7-Eleven Chicken Salad Sandwiches (UPC 7 63913-79486 1) are mislabeled and actually contain tuna salad. The product poses a risk to consumers with tuna allergies.
L & L Homemade Corn Salsa in 16 oz glass jars was voluntarily recalled because the product had a pH of 4.7, identified as unsafe. The recall affected 192 jars distributed in Illinois and Wisconsin.
Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.