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 software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.
A software issue in BD PYXIS MEDBANK automated dispensing cabinets can cause incorrect medication bin labels to print during restocking. This could lead to medication dispensing errors in healthcare facilities.
CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.
Urban River Spirits Vanilla Infused Simple Syrup is being recalled. The product was made in an unlicensed and uninspected facility with potential under-processing, raising food safety concerns.
Urban River Spirits recalls Sunkissed Lavender and Lemon non-alcoholic cocktail mixer (750ml glass bottles) manufactured in an unlicensed, uninspected facility due to potential under-processing concerns.
Urban River Spirits is recalling its Lemon Drop Mixer due to being manufactured in an unlicensed, uninspected facility with potential under-processing concerns affecting product safety. The product was distributed across multiple states.
Urban River Spirits is recalling 3,876 bottles of Spicy Cool-aid: Watermelon & Jalapeno due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.
Cafe Caramel Delight, a non-alcoholic cocktail mixer, is being recalled because it was produced in an unlicensed, uninspected facility with potential under-processing concerns.
Frozen Food Processors recalls frozen cornbread muffins manufactured without state license and in unsanitary conditions. The recall affects approximately 1,862 cases distributed in MS, TN, LA, AR, and AL.
Urban River Spirits voluntarily recalls Velvet Cocoa and Caramel cocktail mixer due to potential under-processing from manufacture in an unlicensed, uninspected facility. Product distributed across 11 states.
Urban River Spirits is recalling Peppered Peach Bliss, a non-alcoholic cocktail mixer, due to potential under-processing risks. The product was manufactured in an unlicensed and uninspected facility.
Urban River Spirits Crisp Cucumber and Mint cocktail mixer recalled due to production in an unlicensed, uninspected facility. Potential under-processing poses a safety risk.
Urban River Spirits is recalling Lush Lavender & Wildberry Spritz non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed and uninspected facility.
Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.
Urban River Spirits is recalling Watermelon Lemonade Splash non-alcoholic mixer due to potential under-processing. The product was manufactured in an unlicensed, uninspected facility, raising food safety concerns.
Urban River Spirits is recalling 3,876 bottles of Cinnamon Infused Simple Syrup due to manufacturing in an unlicensed, uninspected facility with potential under-processing concerns.
Urban River Spirits is recalling Pear-Tini Mixer because it was made in an unlicensed and uninspected facility. The product may not have been properly processed.
Urban River Spirits Life s a Peach Spritzer is recalled because it was manufactured in an unlicensed, uninspected facility with potential under-processing. No illnesses have been reported.
A PEG-3350 oral solution is being recalled nationwide due to defective pouches that may not be properly sealed, risking product leakage. The recall affects 13,200 cartons with lot number S300542.
Urban River Spirits recalls 3876 bottles of Maple Infused Simple Syrup distributed across multiple states. The product was manufactured in an unlicensed, uninspected facility and may be under-processed.
Urban River Spirits is recalling Tropical Lime & Coconut non-alcoholic mixer because it was manufactured in an unlicensed facility with potential under-processing. No illnesses have been reported.
Frozen Food Processors recalls Jalapeno Cornbread Muffins due to manufacturing without state license and in unsanitary conditions. 259 cases were distributed to five states.
Urban River Spirits is recalling Summer Sunset Strawberry and Peach non-alcoholic cocktail mixer from multiple states because it was manufactured in an unlicensed and uninspected facility, creating potential under-processing concerns.
Urban River Spirits recalls Tropical Blackberry cocktail mixer (3,876 bottles) due to manufacturing in an unlicensed, uninspected facility with potential under-processing. No illnesses reported.
The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.