Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strid...
FDA Recall #D-0293-2025 — Class II — March 5, 2025
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
Reason for Recall
Presence of foreign substance: Presence of Benzene.
Recalling Firm
Strides Pharma, Inc. — Chestnut Ridge, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
195,952 Cartons; 30 sachets/Carton.
Distribution
Nationwide in the U.S
Code 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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated