Medications & Supplements/Topical Products

Testosterone Gel 1% Recalled for Defective Container Seal and Leakage

Agency Publication Date: December 3, 2025

Summary

Teva Pharmaceuticals USA, Inc. is recalling 15,944 cartons of Testosterone Gel 1% (2.5 grams per unit dose) due to a defect in the side-seal of the product packets. This defect can allow the gel to leak from the packaging. The recall affects 30-unit dose cartons and individual packets distributed nationwide.

Risk

A defective side-seal allows the product to leak from its container, which may result in skin exposure to the medication for individuals handling the packets or a loss of the required dosage for the patient.

What You Should Do

Check your medication for Testosterone Gel 1% (2.5 grams per unit dose) with lot number 100068692 and an expiration date of 04/30/2027.
Identify the product by the NDC number on the carton (0591-3216-30) or the NDC number on the individual packet (0591-3216-17).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone Gel 1% (2.5 grams per unit dose)

Variants: 2.5 grams per unit dose, Topical Gel, CIII

Lot Numbers:

100068692 (Exp.: 04/30/2027)

NDC:

0591-3216-30

0591-3216-17

Affected product includes both the 30-unit-dose carton and the individual packets inside.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97944

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 15,944 cartons

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication for Testosterone Gel 1% (2.5 grams per unit dose) with lot number 100068692 and an expiration date of 04/30/2027.

Identify the product by the NDC number on the carton (0591-3216-30) or the NDC number on the individual packet (0591-3216-17).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.