# FDA recall D-0442-2024

> **Amneal Pharmaceuticals of New York, LLC** · Class I · drug recall initiated 2024-03-21.

## Product

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle,  NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

## Reason for recall

Superpotent Drug:  Due to overfilling of drug powder

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0442-2024
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-21
- **Report date:** 2024-04-24
- **Termination date:** 2025-07-21

- **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-0442-2024

## Citation

> AI Analytics. FDA recall D-0442-2024. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0442-2024. Source: US FDA. Licensed CC0.

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