Recall: D-0472-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-29Initiated

OngoingStatus

Eugia US LLCFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.