FDA Drug recall D-0245-2025
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc.,…
- FDA Drug
- Class I
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class I recall of Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc.,… by Alvogen, citing defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0245-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alvogen |
| Distribution | US |
Product
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.
Reason
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Identifiers
| ndc | 47781-423-11 |
|---|---|
| ndc | 47781-423-47 |
| ndc | 47781-424-11 |
| ndc | 47781-424-47 |
| ndc | 47781-426-11 |
| ndc | 47781-426-47 |
| ndc | 47781-427-11 |
| ndc | 47781-427-47 |
| ndc | 47781-428-11 |
| ndc | 47781-428-47 |
| code_info | Lot #: 108319, Exp: 04/30/2027 |
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-0245-2025%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.