FDA Drug recall D-0055-2025
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a fo…
- FDA Drug
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a fo… by Noven Pharmaceuticals, citing defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0055-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-31 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
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
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Identifiers
| ndc | 68968-0205-1 |
|---|---|
| ndc | 68968-0205-3 |
| ndc | 68968-0210-1 |
| ndc | 68968-0210-3 |
| ndc | 68968-0215-1 |
| ndc | 68968-0215-3 |
| ndc | 68968-0220-1 |
| ndc | 68968-0220-3 |
| code_info | Lot # 95598, Exp 02/28/25 |
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-0055-2025%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.