FDA Drugs recall ·
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII… recall
- Recall number
- D-0198-2026
- Date
- (initiated November 7, 2025)
- Company / brand
- Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 15,944 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Defective Container - A defect in the side-seal which allows leakage of product.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #100068692, Exp.: 04/30/2027
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0198-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.