# FDA recall D-0507-2019

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2019-01-31.

## Product

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India  NDC 55111-533-01

## Reason for recall

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0507-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-31
- **Report date:** 2019-02-27
- **Termination date:** 2023-02-14

- **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-0507-2019

## Citation

> AI Analytics. FDA recall D-0507-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0507-2019. Source: US FDA. Licensed CC0.

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