Testosterone Gel (Strides Pharma) – Benzene Presence (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Strides Pharma, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Strides Pharma, Inc. is recalling Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pha due to Presence of foreign substance: Presence of Benzene.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of foreign substance: Presence of Benzene.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026