Class IIOngoing

Gentamicin Injection recall

FDA recall D-0472-2025 · initiated May 29, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Eugia Pharma
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: May 29, 2025
FDA report date: Jun 25, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0472-2025 ↗

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