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 fo
Recalled June 25, 2025 · FDA recall D-0472-2025 · Eugia US
Hazard
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. · FDA Class II
Units
48,000 vials
Sold at
Nationwide in the USA
Description
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
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
Manufacturer(s)
Eugia US LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →