# FDA recall D-0015-2015

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2014-09-15.

## Product

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.

## Reason for recall

Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0015-2015
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-15
- **Report date:** 2014-10-22
- **Termination date:** 2017-09-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0015-2015

## Citation

> AI Analytics. FDA recall D-0015-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0015-2015. Source: US FDA. Licensed CC0.

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