Nicotine Transdermal System Patch recall: Impurity Out of Spec
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.
Why was Nicotine Transdermal System Patch recalled?
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 56841, Expires: 03/2028
- 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.
- Recalling firm
- AVEVA Drug Delivery Systems, Inc.
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Distribution
- Nationwide within the U.S
- Recall date
- June 3, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)