Nicotine Transdermal System Patch recall (AVEVA Drug Delivery Systems, Inc.)
DrugClass IIIOngoing
Summary: AVEVA Drug Delivery Systems, Inc. is recalling 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.
What is being recalled
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
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 56841, Expires: 03/2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0550-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | May 14, 2026 |
| Reported | June 3, 2026 |
| Company | AVEVA Drug Delivery Systems, Inc. |
| Company location | Miramar, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 59,808 pouches (4,272 Individual Folding Carton (IFC)) |
More recalls from AVEVA Drug Delivery Systems, Inc. · all drug recalls · recalls from May 2026