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.
A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.
Philips is recalling the Azurion 3 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.
Civco is recalling the eTRAX Needle System Starter Kit 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Burlington Medical is recalling protective vests because of the potential for attenuation degradation over time, decreasing the lifespan of the garment.
Philips is recalling the Azurion 7 B20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
BD is recalling the Kiestra ReadA because after a system reboot one or more modules may become unreachable via the remote connectivity interface, delaying plate retrieval.
Mei Heong Yuen Garlic Flavor Roasted Peanuts (9.17 oz) are being recalled because they contain cyclamates, a banned sweetener. The product was distributed across multiple states.
Mei Heong Yuen tangerine flavor roasted peanuts are recalled because they contain cyclamate, a sweetener banned in the U.S.
The Maros Group, LLC is recalling Mama Rose's Prickly Pear Salad Dressing (12 oz bottles) distributed in Arizona because the product contains undeclared sulfites, which can pose a health risk to people with sulfite sensitivity.
The Maros Group, LLC has recalled Prickly Pear Jelly (9 oz glass bottles) sold in Arizona because the product contains undeclared milk. Consumers with milk allergies should not consume the affected product.
Pocas International Corp. is recalling Popping Boba RTD Mango Passion Fruit Green Tea due to a packaging integrity issue that may compromise product quality.
Pocas International Corp. is recalling Popping Boba RTD Mixed Berry Hibiscus Tea due to a packaging integrity issue that may compromise product quality.
Pocas International Corp. is recalling Popping Boba RTD Strawberry Dragon Fruit Oolong Tea due to a packaging integrity issue that may compromise product quality.
Super World Trading Inc. is recalling Mei Heong Yuen Walnut Flavor Roasted Peanuts (9.17 oz) because the product contains cyclamates, a sweetener banned in the United States.
Pocas International Corp. is recalling Popping Boba RTD Peach Oolong Tea due to a packaging integrity issue that may compromise product quality.
Sevillo Fine Foods is recalling Slow Roasted Diced Tomatoes (24 lb bulk packages, UPC 00823338008216) because the product may contain metal fragments.
Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Distribuidora de Alimentos Sendero LLC is recalling Gorditas de Azucar (UPC 860010238134) distributed in Texas because the product labels do not disclose wheat and soy allergens.
Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
Bakkavor is recalling Basil Pesto & Mozzarella Pizza due to metal fragments discovered in the product. The contamination originated from roasted tomatoes supplied by an ingredient supplier.
Ajinomoto Foods North America is recalling Teppanyaki Style Vegetable Fried Rice due to the presence of glass fragments ranging from 1–3 cm long. Consumers should not eat affected products and should discard or return them.
Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.
Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.