Testosterone Gel
FDA Recall NDC 0591-2921
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Testosterone (NDC 0591-2921). A significant event, classified as Class III, was initiated on Nov 07, 2025 by Actavis Pharma, Inc.. The reported reason for this action was: "Defective Container - A defect in the side-seal which allows leakage of product."
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
November 2025 Class III Recall: Defective Container - A defect in the side-seal which allows leakage of product.
Recall Number
Class III Ongoing
Defective Container - A defect in the side-seal which allows leakage of product.
Nov 07, 2025
Dec 10, 2025
15,944 cartons
Recall Profile & Regulatory Data
Event ID
97944
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
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.
Batch or Lot Expiration Information
Lot# 100068692, Exp.: 04/30/2027
Affected Packages Involved in this Recall
0591-2921-18Product
0591-2921-02Product
0591-3216-17Product
0591-3216-30Product
0591-3217-26Product
0591-3217-30Product
Class II Terminated
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Jun 29, 2022
Aug 03, 2022
12354 cartons
Recall Profile & Regulatory Data
Event ID
90534
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 15, 2024
Product Description
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Batch or Lot Expiration Information
Lot# Lot: 1403180, EXP. 10/2022
Affected Packages Involved in this Recall
0591-2921-18Product
0591-2921-02Product
0591-3216-17Product
0591-3216-30Product
0591-3217-26Product
0591-3217-30Product
Class III Terminated
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Nov 11, 2020
Nov 25, 2020
12,088 cartons
Recall Profile & Regulatory Data
Event ID
86738
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed Nationwide in the USA.
Termination Date
Jun 24, 2021
Product Description
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Batch or Lot Expiration Information
Lot# Lot Number: 1351104, Exp 08/2021
Affected Packages Involved in this Recall
0591-2921-18Product
0591-2921-02Product
0591-3216-17Product
0591-3216-30Product
0591-3217-26Product
0591-3217-30Product
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.
