# FDA recall D-0319-2024

> **Amneal Pharmaceuticals of New York, LLC** · Class II · drug recall initiated 2024-01-15.

## Product

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0319-2024
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-01-15
- **Report date:** 2024-02-14
- **Termination date:** 2025-01-31

- **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-0319-2024

## Citation

> AI Analytics. FDA recall D-0319-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0319-2024. Source: US FDA. Licensed CC0.

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