FDA recall, , Low risk
Aveva Nicotine Transdermal System Patch
The patch failed impurity tests due to elevated oxidative-related impurities.
Summary by Recall Canary from the FDA notice
What happened
AVEVA Drug Delivery Systems, Inc., of Miramar, Florida, is recalling Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, majorpharmaceuticals.com.
The product failed impurities and degradation specifications because elevated levels of oxidative-related impurities exceeded shelf-life specifications during stability testing of individual units. The recall began May 14, 2026, and was added to the FDA's Enforcement Report on May 26, 2026.
The recalled patches were distributed nationwide within the U.S. The recall covers 59,808 pouches (4,272 Individual Folding Carton (IFC)).
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Nicotine Transdermal System Patch
- NDC
- 0536-5895-88
- Lot code
- 56841
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- AVEVA Drug Delivery Systems, Inc.Miramar, Florida
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98972
- Recall number
- D-0550-2026
- Quantity recalled
- 59,808 pouches (4,272 Individual Folding Carton (IFC))
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
