# FDA recall D-1519-2016

> **Unichem Pharmaceuticals Usa Inc** · Class III · drug recall initiated 2016-08-19.

## Product

Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only,  Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.

## Reason for recall

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1519-2016
- **Recalling firm:** Unichem Pharmaceuticals Usa Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-19
- **Report date:** 2016-10-05
- **Termination date:** 2017-02-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1519-2016

## Citation

> AI Analytics. FDA recall D-1519-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1519-2016. Source: US FDA. Licensed CC0.

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