# FDA recall D-0049-2015

> **Taro Pharmaceuticals U.S.A., Inc.** · Class III · drug recall initiated 2014-10-21.

## Product

Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.

## Reason for recall

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system.  An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

## Distribution

IL, OH, LA

## Key facts

- **Recall number:** D-0049-2015
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-21
- **Report date:** 2014-11-05
- **Termination date:** 2017-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hawthorne, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2015

## Citation

> AI Analytics. FDA recall D-0049-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0049-2015. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*