FDA Drug Recalls

Recalls / Active ingredient / Gentamicin Sulfate

Gentamicin Sulfate

3 FDA drug recalls involving the active ingredient “Gentamicin Sulfate.

DateClassProductFirm
2025-05-29Class IIGentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. iEugia US LLC
2014-11-12Class IIGENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP PharFresenius Kabi USA, LLC
2013-05-02Class IIGentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-Hospira Inc.