Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII
Recalled by Teva Pharmaceuticals USA, Inc
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Teva Pharmaceuticals USA, Inc has recalled Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 10, 2025 and was initiated on November 7, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, with approximately 15,944 cartons affected. The company behind the recall is Teva Pharmaceuticals USA, Inc, based in Parsippany, NJ. The FDA describes the product as: “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:…”
Why was Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII recalled?
According to the FDA, the stated reason for the recall is: “Defective Container - A defect in the side-seal which allows leakage of product.”
What should you do?
If you think you may have bought Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, compare it against the product description and identifying codes (Lot #100068692, Exp.: 04/30/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Teva Pharmaceuticals USA, Inc or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 10, 2025
- Recall started
- November 7, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII recalled?+
According to the FDA: Defective Container - A defect in the side-seal which allows leakage of product.
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0198-2026. Information last synced from the FDA on July 6, 2026.