Gentamicin Injection recall
FDA recall D-0472-2025 · initiated May 29, 2025
Eugia US LLC recalled Gentamicin Injection in May 2025 — an FDA Class II recall (D-0472-2025) because Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 48,000 vials
Details
- 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
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 29, 2025
- FDA report date
- Jun 25, 2025
Frequently asked
- Was Gentamicin Injection recalled?
- Eugia US LLC recalled Gentamicin Injection in May 2025 — an FDA Class II recall (D-0472-2025) because Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Gentamicin Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0472-2025 was: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
- Is a recalled Gentamicin Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gentamicin Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0472-2025.