Testosterone recalls

The FDA has published 16 recalls involving Testosterone since 2015. The latest was reported on 10 Dec 2025. Most were for potency & assay. Teva Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls16since 2015

Last 12 months1reported

Class I00% of total

Ongoing5latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 2Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 63%Class III 6 38%

Why testosterone is recalled

Companies

By year

2025319%
202416%
202316%
202216%
202016%
2019213%
2018213%
201716%
2015425%

Ongoing testosterone recalls

5 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS III	Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets recalledTestosterone	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
28 Aug 2024Drug	CLASS II	Testosterone Gel, 62%, (Alcohol 80% v/v)-dose packets recalledTestosterone	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Jan 2017Drug	CLASS II	Testosterone Suspension 100 mg/mL recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide

All testosterone recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS III	Carton label: Testosterone Gel 1% per unit dose, Ciii-dose packets recalledTestosterone	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
2 Apr 2025Drug	CLASS II	Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone	Strides Pharma	Benzene	Nationwide
28 Aug 2024Drug	CLASS II	Testosterone Gel, 62%, (Alcohol 80% v/v)-dose packets recalledTestosterone	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS III	Testosterone Gel, 62% CIII (Alcohol 80% v/v) recalledTestosterone	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Testosterone Gel 1% (25mg testosterone/ of gel) per unit dose recalledTestosterone	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
25 Nov 2020Drug	CLASS III	Testosterone Gel 1% per unit dose recalled by Teva Pharmaceuticals UTestosterone	Teva Pharmaceuticals U	Potency & Assay	Nationwide
10 Jul 2019Drug	CLASS III	Testosterone Topical Solution 30mg of testosterone per pump recalledTestosterone	InvaGen Pharmaceuticals	Other	Nationwide
27 Mar 2019Drug	CLASS III	Testosterone Topical Solution, 30mg recalled by Lupin PharmaceuticalsTestosterone	Lupin Pharmaceuticals	Other	Nationwide
31 Oct 2018Drug	CLASS III	Testosterone Topical Solution, 30mg recalled by Lupin PharmaceuticalsTestosterone	Lupin Pharmaceuticals	Other	Nationwide

Should you stop taking Testosterone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.