Class III

Drug Recall: 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.

AVEVA Drug Delivery Systems, Inc. · May 14, 2026

Reason for Recall

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

Distribution

Nationwide within the U.S

States Affected

NATIONWIDE

Quantity Affected

59,808 pouches (4,272 Individual Folding Carton (IFC))

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0550-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

AVEVA Drug Delivery Systems, Inc. Drug Recall: 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. | SafeCheck