FDA Drugs recall ·
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*)… recall
- Recall number
- D-0472-2025
- Date
- (initiated May 29, 2025)
- Company / brand
- Eugia US LLC
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 48,000 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0472-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.