Class IIIOngoing

Carton label: Testosterone Gel 1% recall

FDA recall D-0198-2026 · initiated Nov 7, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Defective Container - A defect in the side-seal which allows leakage of product.

Details

Product: Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Nov 7, 2025
FDA report date: Dec 10, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0198-2026 ↗

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