FDA recall D-0550-2026

AVEVA Drug Delivery Systems, Inc. · Class III · drug

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.

Reason for recall

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

Distribution

Nationwide within the U.S

Key facts

Status: Ongoing
Initiation date: 2026-05-14
Report date: 2026-06-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miramar, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0550-2026