# FDA recall D-0472-2025

> **Eugia US LLC** · Class II · drug recall initiated 2025-05-29.

## Product

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

## Reason for recall

Failed Stability Specifications:  Out of specification results for the Color Absorbance test during 12 Month sample analysis.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0472-2025
- **Recalling firm:** Eugia US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-29
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2025

## Citation

> AI Analytics. FDA recall D-0472-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0472-2025. Source: US FDA. Licensed CC0.

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