Gentamicin Injection — Class II drug recall D-0472-2025
Ongoing recall by Eugia US LLC, reported 2025-06-25, distributed nationwide. Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sa
| Recall number | D-0472-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2025-05-29 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 48,000 vials |
| Reason classes | specification failure |
| NDC | 55150-0401, 55150-0401-01, 55150-0401-25 |
| Lot numbers | 3GT23006, 3GT23007, 3GT23008 |
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 for recall
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0472-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.