FDA Drug recall D-1277-2019
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058
- FDA Drug
- Class I
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class I recall of FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 by Alvogen, citing product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1277-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-04-19 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alvogen |
| Distribution | US |
Product
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
Reason
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
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#: 180060, Exp 05/2020; 180073, Exp 06/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1277-2019%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.