HIGH

Actavis Recalls Testosterone Gel Due to Leakage Risk

Actavis Laboratories recalled 15,944 cartons of Testosterone Gel on November 7, 2025. The recall follows a defect in the side-seal of the containers, which may allow product leakage. Consumers must stop using the product immediately and contact their healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
November 7, 2025
Hazard Level
HIGH
Brands
TESTOSTERONE, Actavis Pharma, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter

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About This Product

Testosterone Gel is a medication commonly prescribed for testosterone replacement therapy in men with low testosterone levels. It is typically applied topically to the skin.

Why This Is Dangerous

The defect in the side-seal can lead to leakage of the gel, resulting in reduced efficacy of the medication and potential unintended exposure.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face inconvenience in treatment and potential health risks if the product leaks.

Practical Guidance

How to identify if yours is affected

  1. Locate the lot number and expiration date on the packaging.
  2. Check if your product matches Lot #100068692 with an expiration of 04/30/2027.
  3. Verify if the packaging is from Actavis Laboratories, Inc.

Where to find product info

The lot number and expiration date are typically found on the outer box or packet of the product.

What timeline to expect

Expect a timeline of 4-6 weeks for refund processing after contacting the manufacturer.

If the manufacturer is unresponsive

  • Follow up with a second inquiry via phone or email.
  • Consider filing a complaint with the FDA if there is no response.

How to prevent similar issues

  • Always check for recalls before using medications.
  • Inspect packaging for damages before purchasing any medication.
  • Consult a healthcare provider for alternatives if recalls occur.

Documentation advice

Keep all receipts, correspondence, and packaging as evidence for any claims related to the recall.

Product Details

The affected product is Testosterone Gel 1%, packaged in 30 unit-dose packets containing 2.5 grams each. The recall affects Lot #100068692, which expires on April 30, 2027. The product was distributed nationwide in the U.S.

Key Facts

  • Recall date: November 7, 2025
  • Quantity recalled: 15,944 cartons
  • NDC: 0591-3216-30
  • For topical use only
  • Defect: Leakage from side-seal

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #100068692
Exp.: 04/30/2027
UPC Codes
0591-2921
0591-3216
0591-3217
+6 more
Affected States
ALL
Report Date
December 10, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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