November 2025 FDA Recall Testosterone by Teva Pharmaceuticals Usa, Inc
D-0198-2026 - Defective Container - A defect in the side-seal which allows leakage of product.
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on November 7, 2025 for the product Testosterone. The FDA reported the reason for recall as defective container - a defect in the side-seal which allows leakage of product.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0198-2026
Defective Container - A defect in the side-seal which allows leakage of product.
11-07-2025
12-10-2025
15,944 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 100068692, Exp.: 04/30/2027
