Actiq — Class II drug recall D-606-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-06-26, distributed in FL, IL, MA, MO, MS, OH, TX. Failed Dissolution Specification; during stability testing
| Recall number | D-606-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-06-19 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2014-07-23 |
| Distributed | FL, IL, MA, MO, MS, OH, TX |
| Quantity | 316 cartons |
| Reason classes | specification failure |
| NDC | 63459-0502-01, 63459-0502-30 |
| Lot numbers | 06/15, C88583 |
Product
Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
Reason for recall
Failed Dissolution Specification; during stability testing
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-606-2013. 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.