Eugia US LLC is recalling 48,000 vials of Gentamicin Injection, USP (PEDIATRIC) (gentamicin) because the product failed stability testing. During a 12-month analysis, samples showed results for a color absorbance test that were outside of the required safety and quality specifications. The affected product is a 20 mg per 2 mL single-dose vial intended for pediatric use.
Medications that fail color absorbance standards may have undergone chemical changes or degradation. Using a drug that does not meet stability specifications could lead to unpredictable medical outcomes or reduced effectiveness for the patient.
Recall #: D-0472-2025; Mfd. in India for Eugia US LLC
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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