# FDA recall D-0833-2020

> **Taro Pharmaceuticals U.S.A., Inc.** · Class I · drug recall initiated 2019-12-20.

## Product

Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle,  Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

## Reason for recall

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

## Distribution

Nationwide in the U.S. and Puerto Rico.

## Key facts

- **Recall number:** D-0833-2020
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-20
- **Report date:** 2020-02-19
- **Termination date:** 2024-02-23

- **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-0833-2020

## Citation

> AI Analytics. FDA recall D-0833-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0833-2020. Source: US FDA. Licensed CC0.

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