# FDA recall D-1133-2019

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2019-04-11.

## Product

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA

## Reason for recall

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

## Distribution

Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.

## Key facts

- **Recall number:** D-1133-2019
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-11
- **Report date:** 2019-04-24
- **Termination date:** 2020-06-25

- **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-1133-2019

## Citation

> AI Analytics. FDA recall D-1133-2019. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-1133-2019. Source: US FDA. Licensed CC0.

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