Pediatric Gentamicin Injection Recalled Due to Stability Concerns

The US Food and Drug Administration (FDA) has issued a Class II recall for Gentamicin Injection, USP (pediatric), 20 mg per 2 mL (10 mg/mL) single-dose vials, manufactured for Eugia US LLC. The recall affects 48 000 vials from batches 3GT23006, 3GT23007, and 3GT23008, all of which carry an expiration date of November 30, 2025. These products, labeled for prescription use only, were distributed nationwide across the US.

The recall was initiated voluntarily by Eugia US LLC on May 29, 2025, and formally classified by the FDA on June 18, 2025. Although no press release has been issued, notifications were sent by letter to consignees. According to the Enforcement Report, the reason for the recall was out-of-specification results during 12-month stability testing, specifically related to the Color Absorbance test. This failure suggests that the product may exhibit changes in physical characteristics over time, potentially affecting its safety or efficacy profile if administered.

Gentamicin Injection is an aminoglycoside antibiotic used to treat serious bacterial infections, including sepsis, respiratory tract infections, and infections of the bones, joints, urinary tract, and skin, particularly in pediatric patients. Pharmacists are advised to check their inventory for the affected lot numbers and follow proper procedures for return and disposal. The recall remains ongoing, and pharmacists should remain vigilant for any updates.