Dutasteride and Tamsulosin HCl Capsules — Class II drug recall D-0069-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2017-11-08, distributed nationwide. Failed dissolution specifications; all lots within expiry are being recalled due to out of specification disso
| Recall number | D-0069-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-10-25 |
| Classified | 2017-11-02 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2018-05-02 |
| Distributed | Nationwide (US) |
| Quantity | 140,993 bottles |
| Reason classes | specification failure |
| NDC | 00591-3771-19, 00591-3771-30 |
Product
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
Reason for recall
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
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-0069-2018. 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.