Eugia Recalls Gentamicin Injection Due to Stability Failure
Eugia US LLC recalls pediatric Gentamicin Injection vials due to failed stability specifications. Check lot numbers and expiration dates for affected units.
Use caution until it’s fixed
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Contact the company
What happened, in plain English
Eugia US LLC is recalling specific lots of Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL single-dose vials because they failed stability specifications during testing. The product underwent a Color Absorbance test at the 12-month mark which resulted in out-of-specification values. This recall affects approximately 48,000 vials distributed nationwide. Read more at govinfonow.com/recall/32043-eugia-recalls-gentamicin-injection-due-to-stability-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/32043-eugia-recalls-gentamicin-injection-due-to-stability-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0472-2025
Cite this page
“Eugia Recalls Gentamicin Injection Due to Stability Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32043-eugia-recalls-gentamicin-injection-due-to-stability-failure. Based on FDA recall #D-0472-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0472-2025%22&limit=1).
Why it’s dangerous
The recalled vials failed stability specifications for the Color Absorbance test during 12-month sample analysis. While the specific clinical impact is not detailed, failed stability can indicate that the medication may not meet its labeled potency or purity standards over time.
Who’s affected
Healthcare providers and patients who have received or are prescribed Gentamicin Injection, USP (Pediatric) from the affected lots. The risk is primarily related to potential degradation of the drug product affecting its quality.
How to tell if you have this one
Look for Gentamicin Injection, USP (PEDIATRIC), 20 mg per 2 mL (10 mg per mL), 2 mL Single-Dose Vials. The affected products have NDC 55150-401-01 (Vial) and NDC 55150-401-25 (Carton). Affected lots are 3GT23006, 3GT23007, and 3GT23008. The expiration date is November, 30, 2025.
- Brand
Eugia US LLC- Category
Drug
What to do — step by step
Check Lot Numbers
Verify if your vials match lots 3GT23006, 3GT23007, or 3GT23008 with expiration date November, 30, 2025.
Contact Supplier
If you have the affected product, contact your supplier or healthcare provider for instructions on return or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0472-2025 (May 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0472-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.