Recalls / Active ingredient / Testosterone

Testosterone

10 FDA drug recalls involving the active ingredient “Testosterone”.

Date	Class	Product	Firm
2025-11-07	Class III	Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured	Teva Pharmaceuticals USA, Inc
2025-03-05	Class II	Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc.,	Strides Pharma, Inc.
2025-03-05	Class II	Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc	Strides Pharma, Inc.
2024-08-08	Class II	Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. Nor	Teva Pharmaceuticals USA, Inc
2023-11-10	Class III	Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pha	Teva Pharmaceuticals USA, Inc
2022-06-29	Class II	Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box	Teva Pharmaceuticals USA Inc
2020-11-11	Class III	Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Un	Teva Pharmaceuticals USA
2019-06-12	Class III	Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solu	InvaGen Pharmaceuticals, Inc.
2019-03-13	Class III	Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc	Lupin Pharmaceuticals Inc.
2018-10-09	Class III	Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc	Lupin Pharmaceuticals Inc.