Nicotine Transdermal System Patch — Class III drug recall D-0550-2026
Ongoing recall by AVEVA Drug Delivery Systems, Inc., reported 2026-06-03, distributed nationwide. Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf
| Recall number | D-0550-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVEVA Drug Delivery Systems, Inc., Miramar, FL, United States |
| Recall initiated | 2026-05-14 |
| Classified | 2026-05-26 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00536-5894, 00536-5894-53, 00536-5894-88, 00536-5895, 00536-5895-53, 00536-5895-71, 00536-5895-88, 00536-5896, 00536-5896-53, 00536-5896-71, 00536-5896-88 |
| Lot numbers | 56841 |
| Expiration dates | 2028-03 |
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 for recall
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0550-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.