# FDA recall D-0841-2016

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2016-03-30.

## Product

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

## Reason for recall

Failed Impurities/Degradation Specifications; 12 month stability time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0841-2016
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-30
- **Report date:** 2016-05-18
- **Termination date:** 2017-04-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0841-2016

## Citation

> AI Analytics. FDA recall D-0841-2016. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/D-0841-2016. Source: US FDA. Licensed CC0.

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