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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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.

The Hazard

The recall stems from a defect in the side-seal of the packets that can lead to product leakage. This defect poses a potential risk for users, as the gel is intended for topical use only.

Reported Incidents

No injuries or adverse effects have been reported related to the defect at this time. The company is urging consumers to take action to prevent any potential risks.

What to Do

Consumers and healthcare providers should stop using the testosterone gel immediately. Contact Teva Pharmaceuticals USA, Inc. for further guidance regarding the recall.

Contact Information

For more information, consumers can visit the FDA website at www.accessdata.fda.gov or contact Teva Pharmaceuticals USA, Inc.

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

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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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