Tamsulosin Hydrochloride Capsules — Class II drug recall D-1253-2015
Terminated recall by Wockhardt Usa Inc., reported 2015-07-29, distributed nationwide. CGMP Deviations: Firm did not adequately investigate customer complaints.
| Recall number | D-1253-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 407,958 bottles |
| Reason classes | cgmp |
| NDC | 64679-0516-02, 64679-0516-03 |
| Lot numbers | LN10808, LN10896, LN10901, LN10902, LN10903, LN11020, LN11021, LN11055, LN11056, LN11083, LN11084, LN11085, LN11089, LN11109, LN11110, LN11120, LN11121, LN11149, LN11150, LN11186, LN11187, LN11188, LN11206, LN11226, LN11227, LN11233, LN11251, LN11257, LN11262, LN11263, LN11267, LN11274, LN11288, LN11357, LN11370, LN11371, LN11378, LN11384, LN11387, LN11400 and 6 more |
| Expiration dates | 2015-04-30, 2015-05-31, 2015-06-30, 2015-07-31, 2015-08-31, 2015-09-30 |
Product
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
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-1253-2015. 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.