FDA Drug recall D-0550-2026
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorp…
- FDA Drug
- Class III
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class III recall of Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorp… by Aveva Drug Delivery Systems, citing failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0550-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-05-14 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aveva Drug Delivery Systems |
| Distribution | US |
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.
Identifiers
| ndc | 0536-5896-53 |
|---|---|
| ndc | 0536-5896-88 |
| ndc | 0536-5896-71 |
| ndc | 0536-5895-53 |
| ndc | 0536-5895-88 |
| ndc | 0536-5895-71 |
| ndc | 0536-5894-53 |
| ndc | 0536-5894-88 |
| code_info | Lot #: 56841, Expires: 03/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0550-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.