Testosterone Gel
FDA Recall NDC 64380-151
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 64380-151). A significant event, classified as Class II, was initiated on Mar 05, 2025 by Strides Pharma Science Limited. The reported reason for this action was: "Presence of foreign substance: Presence of Benzene."
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
Presence of foreign substance: Presence of Benzene.
Mar 05, 2025
Apr 02, 2025
244,412 Cartons; 30 sachets /Carton
Recall Profile & Regulatory Data
Event ID
96412
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Strides Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
Product Description
Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02
Batch or Lot Expiration Information
Lot# : 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.
Affected Packages Involved in this Recall
64380-152-01Product
64380-152-02Product
64380-151-01Product
64380-151-02Product
Class II Ongoing
Presence of foreign substance: Presence of Benzene.
Mar 05, 2025
Apr 02, 2025
195,952 Cartons; 30 sachets/Carton.
Recall Profile & Regulatory Data
Event ID
96412
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Strides Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S
Product Description
Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
Batch or Lot Expiration Information
Lot# : 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
Affected Packages Involved in this Recall
64380-152-01Product
64380-152-02Product
64380-151-01Product
64380-151-02Product
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.
