Wockhardt Metoprolol Succinate — Class III drug recall D-0304-2015
Terminated recall by Wockhardt Usa Inc., reported 2014-12-24, distributed nationwide. Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability
| Recall number | D-0304-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2014-04-17 |
| Classified | 2014-12-18 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,118,400 extended |
| Reason classes | specification failure |
| NDC | 64679-0735-02, 64679-0735-08 |
| Lot numbers | 12/14, LN10360, LN10392 |
Product
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Reason for recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
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-0304-2015. 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.