Xelstrym — Class II drug recall D-0055-2025
Ongoing recall by Noven Pharmaceuticals Inc, reported 2024-11-27, distributed nationwide. Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
| Recall number | D-0055-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Noven Pharmaceuticals Inc, Miami, FL, United States |
| Recall initiated | 2024-10-31 |
| Classified | 2024-11-19 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 685 boxes |
| NDC | 68968-0205, 68968-0205-01, 68968-0205-03, 68968-0210, 68968-0210-01, 68968-0210-03, 68968-0215, 68968-0215-01, 68968-0215-03, 68968-0220, 68968-0220-01, 68968-0220-03 |
| Lot numbers | 95598 |
| Expiration dates | 2025-02-28 |
Product
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
Reason for recall
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
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-0055-2025. 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.