Tamsulosin Hydrochloride Capsules — Class II drug recall D-1844-2019
Terminated recall by Macleods Pharma Usa Inc, reported 2019-08-21, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1844-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2019-07-17 |
| Classified | 2019-08-28 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2021-02-09 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 33342-0159, 33342-0159-07, 33342-0159-11, 33342-0159-12, 33342-0159-15, 33342-0159-44 |
| Expiration dates | 2020-07, 2020-08, 2020-12 |
Product
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
Reason for recall
Failed Dissolution 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-1844-2019. 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.