Eugia US LLC recalls Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India f…

Recall date

May 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0472-2025

FDA classification

Class II

Brand / firm

Eugia US LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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