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FDA · Drugs ·

Nicotine Transdermal System Patch recall

AVEVA Drug Delivery Systems, Inc. recalled Nicotine Transdermal System Patch on June 3, 2026 because of failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. It was sold nationwide.

Why it was recalled

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

What's recalled

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.

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

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice