May 2025 FDA Recall Gentamicin by Eugia Us Llc
D-0472-2025 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Eugia Us Llc on May 29, 2025 for the product Gentamicin. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0472-2025
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
05-29-2025
06-25-2025
48,000 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
