FDA Drug Recalls

Recalls / Generics / Testosterone

Testosterone

10 FDA drug recalls involving generic “Testosterone.

DateClassProductFirm
2025-11-07Class IIICarton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured Teva Pharmaceuticals USA, Inc
2025-03-05Class IITestosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., Strides Pharma, Inc.
2025-03-05Class IITestosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma IncStrides Pharma, Inc.
2024-08-08Class IITestosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. NorTeva Pharmaceuticals USA, Inc
2023-11-10Class IIITestosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva PhaTeva Pharmaceuticals USA, Inc
2022-06-29Class IITestosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per boxTeva Pharmaceuticals USA Inc
2020-11-11Class IIITestosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 UnTeva Pharmaceuticals USA
2019-06-12Class IIITestosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of soluInvaGen Pharmaceuticals, Inc.
2019-03-13Class IIITestosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals IncLupin Pharmaceuticals Inc.
2018-10-09Class IIITestosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals IncLupin Pharmaceuticals Inc.