# FDA recall D-0255-2022

> **UNICHEM PHARMACEUTICALS USA INC** · Class III · drug recall initiated 2021-10-25.

## Product

Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India.  Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05.

## Reason for recall

Discoloration

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0255-2022
- **Recalling firm:** UNICHEM PHARMACEUTICALS USA INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-25
- **Report date:** 2021-12-01
- **Termination date:** 2022-10-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2022

## Citation

> AI Analytics. FDA recall D-0255-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0255-2022. Source: US FDA. Licensed CC0.

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