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.
DSD Merchandisers recalls Deluxe Roasted Salted Mixed Nuts (Item 99651) for undeclared peanut allergen, with distribution in six western states and a sell-by date of October 9, 2024. Consumers with peanut allergies should not consume this product.
StellaLife VEGA Oral Care spray bottles have been recalled due to contamination with multiple Bacillus species organisms. The FDA Class I recall affects 31,811 bottles distributed nationwide to physician offices.
Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.
Solata Food LLC is recalling multiple brands of greens products distributed in NY, NJ, and NH due to potential Listeria monocytogenes contamination. Affected products, totaling 4,382 lbs with expiration dates of June 20–24, 2024, should not be consumed.
Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.
Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules (750 mg) nationwide due to failed dissolution specifications that may affect medication delivery. Approximately 36,630 bottles are affected.
Solata Food LLC is recalling organic spring mix products for potential Listeria monocytogenes contamination. The recall affects products distributed in NY, NJ, and NH with expiration dates 6/20/24 and 6/24/24.
Multiple spinach products from various brands are being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in New York, New Jersey, and New Hampshire.
Aahu Barah Apricot Roll (14 oz, UPC 882475000279) is being recalled because it contains elevated levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.
Terrafina macadamia nuts are being recalled because they tested positive for salmonella. The product was distributed in New Jersey and New York.
Solata Food LLC is recalling Greens Farmer Direct Organic Chopped Kale Spinach due to potential Listeria monocytogenes contamination. The product may pose a serious health risk.
Solata Food LLC is recalling three brands of spring mix herb products sold in NY, NJ, and NH due to potential contamination with Listeria monocytogenes, a bacterium that can cause serious illness.
Solata Food LLC is recalling multiple Power Greens products due to potential Listeria monocytogenes contamination. Affected products were distributed in NY, NJ, and NH with expiration dates of 6/20/24 and 6/24/24.
Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.
Abbott recalls 1,086 Proclaim Plus 7 implantable pulse generators due to labeling inaccuracy. Devices may reach end of service sooner than labeled, potentially reducing the time patients have to plan for replacement.
Snapchill, LLC is recalling approximately 549,146 cans of Perkatory Coffee Roasters Three Witches Blend due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.
The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.
Snapchill, LLC is recalling 549,146 cans of Coffee Hound and White Rhino coffee beverages for potential under-processing. Affected cans with expiration dates June 16, 2024–April 16, 2025 were distributed nationwide and in Canada.
Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.
Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.
Wehah Farms is recalling Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object of apparent rodent origin. Consumers should not consume the recalled product.
Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.
Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.
Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.
Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.