Drug FDA Class III Ongoing Failed specifications
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.
AVEVA Drug Delivery Systems, Inc. Published Jun 3, 2026
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact AVEVA Drug Delivery Systems, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Hazards
Oxidative-related impurities · primary
Affected products (1)
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.
NICOTINE · 59,808 pouches (4,272 Individual Folding Carton (IFC))
NDC: 0536-5894, 0536-5896, 0536-5895, 0536-5896-53, 0536-5896-88, 0536-5896-71, 0536-5895-53, 0536-5895-88, 0536-5895-71, 0536-5894-53, 0536-5894-88
Code info: Lot #: 56841, Expires: 03/2028
Affected areas
Nationwide
Timeline
- InitiatedMay 14, 2026
- PublishedJun 3, 2026
- Recall number
- D-0550-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.