FDAClass IIJune 25, 2025

Gentamicin Injection recall

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…

Why was Gentamicin Injection recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025

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…
Recalling firm
Eugia US LLC
Quantity
48,000 vials
Distribution
Nationwide in the USA
Recall date
June 25, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls