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Drug FDA Class II Ongoing Failed specifications

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

Eugia US LLC Published Jun 25, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Color Absorbance Stability Test · primary

Affected products (1)

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

GENTAMICIN · 48,000 vials

NDC: 55150-401, 55150-401-01, 55150-401-25
Code info: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025

Affected areas

Nationwide

Timeline

  1. Initiated
    May 29, 2025
  2. Published
    Jun 25, 2025
Recall number
D-0472-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.