Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Br
Summary
The FDA issued a Class II for Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Dist by Strides Pharma, Inc.. Reason: Presence of foreign substance: Presence of Benzene..
Details
Source
Drug Recall
External ID
D-0293-2025
Action Date
2025-04-02
Status
Ongoing
Category
drug
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
Lot/Code Info: 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
Quantity Affected: 195,952 Cartons; 30 sachets/Carton.
Reason for Recall
Presence of foreign substance: Presence of Benzene.
Distribution
Nationwide in the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-05
Company
Chestnut Ridge, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 81 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Strides Pharma, Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Strides Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Strides Pharma, Inc. have FDA actions?
Strides Pharma, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0293-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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