Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose Recalled by Teva Pharmaceuticals USA Inc Due to Superpotent Drug: Out of specification assay result was...

Date: June 29, 2022
Company: Teva Pharmaceuticals USA Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA Inc directly.

Affected Products

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30

Quantity: 12354 cartons

Why Was This Recalled?

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA Inc

Teva Pharmaceuticals USA Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report