CLASS II ONGOING Drug recall · Reported 25 Jun 2025 · FDA Enforcement Report
Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia US
Eugia US is recalling Gentamicin Injection, USP, (Pediatric), 20 mg per (10 mg per mL*) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 29 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0472-2025
- FDA event ID
- 96976
- Recalling firm
- Eugia US, East Windsor, NJ
- Brand
- Gentamicin
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2025
- FDA classified
- 18 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 29 May 2025 | Recall initiated by company | |
| 18 Jun 2025 | Classified by FDA | +20 days |
| 25 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Which lots are affected?
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eugia US
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lidocaine HCl Injection, USP 2%, 40 mg recalled by Eugia USLidolog Kit | Eugia US | Other | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirofiban Hydrochloride Injection 12.5 mg recalled by Eugia USTirofiban | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL recalledMedroxyprogesterone Acetate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
Other Gentamicin recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Ointment USP 0.1%, packaged as a) tube recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin 80mg/ Irrigation, containers recalled | The Medicine Shoppe Pharmacy | Sterility | FL |
| Drug | CLASS II | Gentamicin 120 mg/ 0.9% Sodium Chloride recalled | Anderson Compounding Pharmacy | Sterility | Nationwide |