# FDA recall D-1362-2022

> **Amneal Pharmaceuticals of New York, LLC** · Class II · drug recall initiated 2022-07-27.

## Product

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10

## Reason for recall

Failed dissolution specifications.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-1362-2022
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-27
- **Report date:** 2022-08-31
- **Termination date:** 2023-08-17

- **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-1362-2022

## Citation

> AI Analytics. FDA recall D-1362-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1362-2022. Source: US FDA. Licensed CC0.

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