Class IIIOngoing

Nicotine Transdermal System Patch recall

FDA recall D-0550-2026 · initiated May 14, 2026

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

Details

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.
Recalling company: AVEVA Drug Delivery Systems, Inc.
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the U.S
Initiated: May 14, 2026
FDA report date: Jun 3, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0550-2026 ↗

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