# FDA recall D-0426-2024

> **Amneal Pharmaceuticals of New York, LLC** · Class II · drug recall initiated 2023-12-26.

## Product

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

## Reason for recall

Failed dissolution specifications

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0426-2024
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-12-26
- **Report date:** 2024-04-03
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brookhaven, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2024

## Citation

> AI Analytics. FDA recall D-0426-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/D-0426-2024. Source: US FDA. Licensed CC0.

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