AVEVA Drug Delivery Systems, Inc. recalls Nicotine Transdermal System Patch
- Recalling company
- AVEVA Drug Delivery Systems, Inc.
- 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
- Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- May 14, 2026
- Reported
- Jun 3, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Lot / codes
- Lot #: 56841, Expires: 03/2028
- Company location
- Miramar, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0550-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0550-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.