FDA Drugs recall ·
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva… recall
- Recall number
- D-0550-2026
- Date
- (initiated May 14, 2026)
- Company / brand
- AVEVA Drug Delivery Systems, Inc.
3250 Commerce Pkwy, Miramar, FL, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 56841, Expires: 03/2028
Distribution
Nationwide within the U.S
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0550-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.