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.
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets after a labeling error swapped 2.5 mg and 5 mg strengths.
Reliance Life Sciences is recalling Azacitidine for Injection 100mg/Vial nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.
Fresh to You Burger Chicken Fillet Deluxe with Bacon (SKU 10303) is being recalled because raw breaded chicken patties were inadvertently used instead of cooked patties, posing a risk of Salmonella contamination.
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
Fresh to You Burger Chicken Fillet sandwiches are being recalled because raw breaded chicken patties were inadvertently used instead of cooked ones, creating a risk of Salmonella foodborne illness.
Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/Vial nationwide due to lack of sterility assurance. The affected product may not meet required sterility standards for intravenous use.
Adams Extract & Spice LLC is recalling EC Hot Links Seasoning 45.05# due to undeclared sesame allergen. The product may pose a serious health risk to consumers with sesame allergies.
Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.
Trafa Pharmaceuticals Inc. is recalling Organic Moringa Leaf Powder due to potential Salmonella contamination. Affected product is Batch #TRF-2025050801, distributed in New York.
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays used in knee replacement surgery because the knob on the tracking array may loosen, causing potential misalignment of the array.
Adams Extract & Spice LLC is recalling Johnny's Salad and Pasta Elegance seasoning products because they contain undeclared sesame, a known allergen. The recall affects two product sizes distributed in Texas.
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Wondermade LLC is recalling Alabama Banana Pudding Marshmallow products because they may contain small metal pieces. The affected 4-ounce boxes were distributed to Pennsylvania, Texas, Indiana, and Florida.
High Valley Orchard Chocolate Covered Raisins (15oz bags) are recalled nationwide due to undeclared peanut from mis-packaging. Consumers with peanut allergies should not consume this product.
Adams Extract & Spice LLC is recalling JB Chicken Sknls 35.73# due to undeclared sesame allergen. Consumers with sesame allergies who consume the product face a risk of allergic reaction.
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Specialty Bakers, LLC is recalling Vanilla Dessert Shells (Giant) because they contain soy that is not declared on the label, posing a risk to consumers with soy allergies.
Adams Extract & Spice LLC is recalling Smoked Sausage Spice due to undeclared sesame allergen. Consumers with sesame allergies should not use the affected product.
Adams Extract & Spice LLC is recalling Coopers BBQ 60 Gallon Bean Mix boxes due to undeclared sesame allergen. The product was distributed in Texas.
Bear Stewart Co is recalling Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough due to undeclared soy. The product was distributed in Southern California, Southern Nevada, Arizona, and Utah through Target stores.