Tamsulosin Hydrochloride Capsules — Class II drug recall D-1066-2019
Terminated recall by Ascend Laboratories LLC, reported 2019-03-13, distributed nationwide. Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stabilit
| Recall number | D-1066-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2019-02-22 |
| Classified | 2019-03-29 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-03-18 |
| Distributed | Nationwide (US) |
| Quantity | 3,072 bottles |
| Reason classes | specification failure |
| NDC | 67877-0450, 67877-0450-01, 67877-0450-05, 67877-0450-10, 67877-0450-30, 67877-0450-33, 67877-0450-38, 67877-0450-60 |
| Lot numbers | 8144652 |
| Expiration dates | 2020-07-20 |
Product
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05.
Reason for recall
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed 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-1066-2019. 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.