FDA Drug recall D-0304-2015
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-…
- FDA Drug
- Class III
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class III recall of Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-… by Wockhardt Usa, citing failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0304-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-17 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wockhardt Usa |
| Distribution | US |
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
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Identifiers
| code_info | a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2017-11-01 · Wockhardt Usa - Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa - Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa - Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-71…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa - Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 6467…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0304-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.