FENTANYL Transdermal System — Class I drug recall D-1277-2019
Terminated recall by Alvogen, Inc, reported 2019-05-15, distributed nationwide. Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contain
| Recall number | D-1277-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alvogen, Inc, Pine Brook, NJ, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2019-05-13 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2019-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 119,608 cartons |
| Reason classes | labeling |
| 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 | 180060, 180073 |
| Expiration dates | 2020-05, 2020-06 |
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 for recall
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.
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-1277-2019. 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.