FDAMay 14, 2026drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

aveva drug delivery systemsavevaaveva drug

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear