FDAFDA · Food and drugs·Recall number 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.
Published June 3, 2026 · Recall initiated: May 14, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NICOTINE
- Manufacturer
- AVEVA Drug Delivery Systems, Inc.
- Distributor
- Nationwide within the U.S
- Lot
- Lot #: 56841, Expires: 03/2028
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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