FDAHealthMay 14, 2026
AVEVA Drug Delivery Systems, Inc. — Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0
⚠️ Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 14, 2026
Nationwide within the U.S
What's affected?
- 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.
- Brand
- NICOTINE
- Lot code
- 56841
Additional details
Lot #: 56841, Expires: 03/2028
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 59,808 pouches (4,272 Individual Folding Carton (IFC)).
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