# FDA recall D-0491-2024

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2024-04-24.

## Product

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

## Reason for recall

Discoloration: Dotted and yellow spots on tablets

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0491-2024
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-24
- **Report date:** 2024-05-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2024

## Citation

> AI Analytics. FDA recall D-0491-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0491-2024. Source: US FDA. Licensed CC0.

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