# FDA recall D-0617-2017

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2017-03-15.

## Product

Divalproex Sodium Delayed Release Tablets, USP, 500 mg,  a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ

## Reason for recall

Failed Dissolution Specifications; 9 month long term stability

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0617-2017
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-15
- **Report date:** 2017-04-05
- **Termination date:** 2020-09-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2017

## Citation

> AI Analytics. FDA recall D-0617-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0617-2017. Source: US FDA. Licensed CC0.

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