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.
JLM Manufacturing Dark Chocolate Nonpareils in 14 oz tubs are being recalled because of undeclared milk. 971 cases are affected, distributed nationwide.
Vampire Slayer Garlic Cheddar Cheese Curds are being recalled because they have the potential to be contaminated with Listeria monocytogenes. 260 cases are affected.
Weaver Chocolates Nonpareil Semi-Sweet Chocolate (White Seeds) in 25 lb bulk cases is being recalled because of an undeclared milk allergen. 1,760 cases are affected.
Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.
Wegmans brand Chocolate Chip Mini Muffins are being recalled because the product may contain foreign objects of metal origin. 8,508 units are affected.
Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.
Crown Point Shelled Edamame in 22 lb cases is being recalled because the label declares shelled edamame but does not specify or declare soy. 1,046 cases are affected.
C Sweet Ghouribeh with Pistachios is being recalled because soy is undeclared and the contains statement, though present, does not list pistachios. 30 units are affected.
VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.
Wegmans brand Blueberry Mini Muffins family pack is being recalled because the product may contain foreign objects of metal origin. 8,508 units are affected.
Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.
Duloxetine Delayed-Release Capsules 40 mg are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 12,242 bottles are affected.
C Sweet Ghouribeh Rolls with date, sesame and pistachios are being recalled because wheat, soy and sesame are undeclared. 30 units are affected.
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.
Wegmans brand French Toast Mini Muffins are being recalled because the product may contain foreign objects of metal origin. 8,508 units are affected.
C Sweet Sweet Kaak is being recalled because of undeclared wheat. 20 units are affected, distributed in Michigan.
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.
Wegmans Semi-Sweet Chocolate Nonpareils are being recalled because of undeclared milk. 595 cases are affected across nine states and the District of Columbia.
C Sweet Maamoul with Pistachios is being recalled because soy is undeclared and the contains statement, though present, does not list pistachios. 40 units are affected.
Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
C Sweet Maamoul with Dates is being recalled because of undeclared soy and wheat. 40 units are affected, distributed in Michigan.
Daniele brand First Cold Press Extra Virgin Olive Oil in 3 L containers is being recalled because the product is likely canola oil, not extra virgin olive oil. 10 cases are affected.