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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Eugia US LLC
- Reason for Recall:
- Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0472-2025
Related Recalls
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.