Gentamicin Injection Pediatric Vials Recalled for Failed Stability Tests
Eugia US LLC is recalling Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL due to failed color absorbance test results during 12-month stability analysis. The recall affects 48,000 vials distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a failed stability specification (color absorbance test), which is a quality/integrity concern that typically warrants precautionary action but does not meet the higher thresholds for High or Severe classification.
Plain-English summary
Eugia US LLC is recalling Gentamicin Injection, USP (Pediatric), 20 mg per 2 mL (10 mg per mL), in 2 mL single-dose vials. The recall was initiated because out-of-specification results were found for the Color Absorbance test during 12-month sample analysis, indicating that the product failed its stability specifications.
The affected product includes 48,000 vials from batches 3GT23006, 3GT23007, and 3GT23008, with an expiration date of November 30, 2025. These vials have been distributed nationwide in the United States. The product is manufactured in India for Eugia US LLC, located in East Windsor, New Jersey.
Patients and healthcare providers who have this medication should contact their pharmacist or healthcare provider. Do not use the recalled product.
The recalled product
- Product
- GENTAMICIN (GENTAMICIN)
- Brand
- GENTAMICIN
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 48,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Batch 3GT23006
- 3GT23007
- 3GT23008
- Exp Date: November
- 30
- 2025
Distribution
Distributed nationwide across the United States.
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