Fentanyl Transdermal System — Class III drug recall D-599-2013
Terminated recall by Actavis, reported 2013-06-19, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-599-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis, Salt Lake City, UT, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-06-12 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2014-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 98,952 boxes |
| Reason classes | specification failure |
| NDC | 00591-3212-54, 00591-3212-72 |
Product
Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 92880 USA; Distributed by: Watson Pharma, Inc.
Reason for recall
Failed Impurities/Degradation Specifications
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-599-2013. 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.