Official recall notice

FDA DrugClass IIINotable

Nicotine Transdermal System Patch Recall (Jun 2026)

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.

Recall date
2026-06-03
Category
Drug
FDA class
Class III

Why it was recalled

Hazard

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

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Product description

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

Verify with the official notice →
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