Why it was recalled
Defective Container - A defect in the side-seal which allows leakage of product.
Product description
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Lot numbers, UPCs & expiration codes
Lot #100068692, Exp.: 04/30/2027
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0198-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 7, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 15,944 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0198-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97944
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #100068692, Exp.: 04/30/2027
- Postal code
- 07054-1120
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0198-2026
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 15,944 cartons
- Reason for recall
- Defective Container - A defect in the side-seal which allows leakage of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Nov 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2025