FDAFDA · Food and drugs·Recall number D-0198-2026
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.
Published December 10, 2025 · Recall initiated: November 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container - A defect in the side-seal which allows leakage of product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot #100068692, Exp.: 04/30/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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