# FDA recall D-0304-2015

> **Wockhardt Usa Inc.** · Class III · drug recall initiated 2014-04-17.

## 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.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0304-2015
- **Recalling firm:** Wockhardt Usa Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-17
- **Report date:** 2014-12-24
- **Termination date:** 2015-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2015

## Citation

> AI Analytics. FDA recall D-0304-2015. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0304-2015. Source: US FDA. Licensed CC0.

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