Medications & Supplements/Prescription Drugs

Teva Testosterone Gel Recalled for Superpotency

Agency Publication Date: August 16, 2024

Summary

Teva Pharmaceuticals USA, Inc. is recalling 7,080 unit-dose packets of its 1.62% Testosterone Gel. This medication is being recalled because it was found to be superpotent, meaning it contains more of the active testosterone ingredient than intended. Using a superpotent drug can lead to a higher dose of the medication than prescribed, which may result in adverse health effects.

Risk

Exposure to excess levels of testosterone through superpotent gel can disrupt hormone balance and lead to unintended side effects. No specific injuries or incidents have been reported in the current data, but patients should seek medical advice regarding continued use.

What You Should Do

The recalled product is Teva Pharmaceuticals Testosterone Gel, 1.62% (Alcohol 80% v/v), sold in 30 unit-dose packets for prescription use.
Check your medication for Lot number 100042386 with an expiration date of June 2025 (06/2025). The carton has NDC 0591-2925-30 and individual packets have NDC 0591-2925-32.
If you have health concerns or notice unusual symptoms, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 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, 1.62% (Alcohol 80% v/v)

Variants: 30 unit-dose packets, Rx Only

Lot Numbers:

100042386 (Exp 06/2025)

NDC:

0591-2925-30

0591-2925-32

Carton NDC # 0591-2925-30; Packet NDC # 0591-2925-32.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95122

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 7,080 unit dose packets

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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

The recalled product is Teva Pharmaceuticals Testosterone Gel, 1.62% (Alcohol 80% v/v), sold in 30 unit-dose packets for prescription use.

Check your medication for Lot number 100042386 with an expiration date of June 2025 (06/2025). The carton has NDC 0591-2925-30 and individual packets have NDC 0591-2925-32.

If you have health concerns or notice unusual symptoms, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA, Inc. for further instructions.

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