Fentanyl Transdermal System — Class III drug recall D-0540-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2018-02-14, distributed nationwide. Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification lim
| Recall number | D-0540-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-01-29 |
| Classified | 2018-02-22 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-09-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00591-3198-54, 00591-3198-72 |
| Lot numbers | 1103907A, 1114170A, 1117212A, 1130863A, 1140570A, 1153178A, 1153185A, 1171608A, 1188715A, 1193264A, 1208789A, 1212340A, 1225166A, 1238442A |
| Expiration dates | 2018-03-20, 2018-04-20, 2018-05-20, 2018-07-20, 2018-08-20, 2018-09-20, 2018-11-20, 2019-01-20, 2019-04-20, 2019-07-20, 2019-08-20 |
Product
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
Reason for recall
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
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-0540-2018. 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.