FDA Drug recall D-0472-2025
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.…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of 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.… by Eugia Us, citing failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0472-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-29 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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
Reason
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Identifiers
| ndc | 55150-401-01 |
|---|---|
| ndc | 55150-401-25 |
| code_info | Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0472-2025%22
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