Testosterone Gel
FDA Recall NDC 0591-2926
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Testosterone (NDC 0591-2926). A significant event, classified as Class II, was initiated on Aug 08, 2024 by Actavis Pharma, Inc.. The reported reason for this action was: "Superpotent Drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Superpotent Drug
Aug 08, 2024
Aug 28, 2024
7,080 unit dose packets
Recall Profile & Regulatory Data
Event ID
95122
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States
Product Description
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Batch or Lot Expiration Information
Lot# : 100042386, Exp. Date 06/2025
Affected Packages Involved in this Recall
0591-2924-18Product
0591-2925-32Product
0591-2925-30Product
0591-2926-25Product
0591-2926-30Product
Class III Terminated
OOS for viscosity
Nov 10, 2023
Dec 06, 2023
N/A
Recall Profile & Regulatory Data
Event ID
93409
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Jun 03, 2024
Product Description
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Batch or Lot Expiration Information
Lot# : 100029472, Exp. 2/29/2024
Affected Packages Involved in this Recall
0591-2924-18Product
0591-2925-32Product
0591-2925-30Product
0591-2926-25Product
0591-2926-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
