# FDA recall D-0090-2024

> **Amneal Pharmaceuticals of New York, LLC** · Class II · drug recall initiated 2023-10-27.

## Product

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0090-2024
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-10-27
- **Report date:** 2023-11-15
- **Termination date:** 2025-08-06

- **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-0090-2024

## Citation

> AI Analytics. FDA recall D-0090-2024. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/D-0090-2024. Source: US FDA. Licensed CC0.

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