# FDA recall D-1583-2019

> **MAJOR PHARMACEUTICALS** · Class II · drug recall initiated 2019-04-24.

## Product

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1583-2019
- **Recalling firm:** MAJOR PHARMACEUTICALS
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-24
- **Report date:** 2019-08-07
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** N/A
- **Location:** Livonia, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1583-2019

## Citation

> AI Analytics. FDA recall D-1583-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1583-2019. Source: US FDA. Licensed CC0.

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