Fentanyl Transdermal System CII — Class I drug recall D-0245-2025
Ongoing recall by Alvogen, Inc, reported 2025-02-26, distributed nationwide. Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single produ
| Recall number | D-0245-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Morristown, NJ, United States |
| Recall initiated | 2025-01-31 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| NDC | 47781-0423, 47781-0423-11, 47781-0423-47, 47781-0424, 47781-0424-11, 47781-0424-47, 47781-0426, 47781-0426-11, 47781-0426-47, 47781-0427, 47781-0427-11, 47781-0427-47, 47781-0428, 47781-0428-11, 47781-0428-47 |
| Lot numbers | 108319 |
| Expiration dates | 2027-04-30 |
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 for recall
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
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-0245-2025. 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.