Gentamicin Injection, Solution
FDA Recall NDC 55150-401
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gentamicin (NDC 55150-401). A significant event, classified as Class II, was initiated on May 29, 2025 by Eugia Us Llc. The reported reason for this action was: "Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
May 29, 2025
Jun 25, 2025
48,000 vials
Recall Profile & Regulatory Data
Event ID
96976
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Affected Packages Involved in this Recall
55150-401-01Product
55150-401-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
