# FDA recall D-0215-2017

> **Impax Laboratories, Inc.** · Class I · drug recall initiated 2016-08-19.

## Product

Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA

## Reason for recall

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

## Distribution

Distributed Nationwide

## Key facts

- **Recall number:** D-0215-2017
- **Recalling firm:** Impax Laboratories, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-19
- **Report date:** 2016-12-28
- **Termination date:** 2017-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hayward, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2017

## Citation

> AI Analytics. FDA recall D-0215-2017. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/D-0215-2017. Source: US FDA. Licensed CC0.

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