AVEVA Drug Delivery Systems, Inc. recalls Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, I
Recalled June 3, 2026 · FDA recall D-0550-2026 · AVEVA Drug Delivery Systems
Hazard
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. · FDA Class III
Units
59,808 pouches (4,272 Individual Folding Carton (IFC))
Sold at
Nationwide within the U.S
Description
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Product
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Manufacturer(s)
AVEVA Drug Delivery Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →