Medications & Supplements/Prescription Drugs

Actavis Testosterone Gel 1% Recalled for Superpotency

Agency Publication Date: July 25, 2022

Summary

Actavis Testosterone Gel 1% (25mg testosterone/2.5g of gel) is being recalled by Teva Pharmaceuticals USA Inc because stability testing revealed the drug may be superpotent. Approximately 12,354 cartons of this prescription medication are affected by the recall. No incidents or injuries have been reported to date regarding this issue.

Risk

The drug is superpotent, meaning it contains more of the active ingredient than specified on the label. Using a dose higher than prescribed can lead to unintended hormonal side effects or complications.

What You Should Do

The recalled product is Actavis Testosterone Gel 1% (25mg testosterone/2.5g of gel), packaged in 30 unit-dose packets per box with sachet NDC 0591-3216-17 and carton NDC 0591-3216-30.
Check your medication for lot number 1403180 with an expiration date of 10/2022.
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 Teva Pharmaceuticals USA Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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% (25mg testosterone/2.5g of gel)by Actavis

Variants: 2.5 g per unit dose, 30 unit-dose packets per box

Lot Numbers:

1403180 (Exp. 10/2022)

NDC:

0591-3216-17

0591-3216-30

Manufactured by Actavis Laboratories UT, Inc.; Distributed by Actavis Pharma, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90534

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 12354 cartons

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 Actavis Testosterone Gel 1% (25mg testosterone/2.5g of gel), packaged in 30 unit-dose packets per box with sachet NDC 0591-3216-17 and carton NDC 0591-3216-30.

Check your medication for lot number 1403180 with an expiration date of 10/2022.

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 Teva Pharmaceuticals USA Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.