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.
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.
ADVANTA VXT vascular grafts are recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units worldwide are affected.
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.
Schreiber Foods Inc is recalling 835,721 units of Essential Everyday Blueberry Cream Cheese Spread (8 oz) due to potential Salmonella contamination. No illnesses have been reported.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.
Atrium Medical is recalling ADVANTA VXT vascular grafts following complaints of separation between the slider component and swivel core.
The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
Charles Boggini Company is recalling Yellow Lemonade and Yellow Lemonade X (1 and 5 gallon sizes) due to undeclared FD&C Yellow No. 5. Consumers with tartrazine sensitivity should not consume the affected products.
Rising Pharma's pregabalin capsules are being recalled nationwide after a pantoprazole tablet was discovered during packaging. No illnesses have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.
Charles Boggini Pink Lemonade in 1 and 5-gallon sizes is recalled for containing undeclared FD&C Red No. 40. The colorant was not listed on product labels.
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
Bryant Ranch Prepack is recalling Cephalexin oral suspension bottles due to incorrect labeling that states tablet information instead of liquid suspension details and omits the total dose per bottle.
Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.
Gibson Farms Organic Nuts – Light Halves and Pieces are recalled due to potential E. coli O157:H7 contamination. Affected lots 3325-043 and 3341-501 were distributed to California and Washington.
Hy-Vee Stores Inc is recalling Hy-Vee To Go and Hy-Vee Cookies & Cream Mix products due to potential Salmonella contamination. Affected products were distributed in eight Midwest states.
Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.
Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.