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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- TESTOSTERONE, Actavis Pharma, Inc.
- Product type
- Testosterone Gel
- Model numbers
- Lot #100068692, Exp.: 04/30/2027
- UPC codes
- 0591-2921, 0591-3216, 0591-3217, 0591-2921-18, 0591-2921-02, 0591-3216-17, 0591-3216-30, 0591-3217-26 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 7, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Locate the lot number and expiration date on the packaging.
- Check if your product matches Lot #100068692 with an expiration of 04/30/2027.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- For topical use only
- Defect: Leakage from side-seal
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.