FDA Drug · D-0550-2026

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.

Class III · Ongoing

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

Affected lots / codes — check yours against thisLot #: 56841, Expires: 03/2028

Recalling firm: AVEVA Drug Delivery Systems, Inc., Miramar, FL
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 59,808 pouches (4,272 Individual Folding Carton (IFC))
Distribution: Nationwide within the U.S
Recall initiated: May 14, 2026
Classified: May 26, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0550-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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