FDA recall D-0294-2025

Strides Pharma, Inc. · Class II · drug

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

Reason for recall

Presence of foreign substance: Presence of Benzene.

Distribution

Nationwide in the U.S

Key facts

Status: Ongoing
Initiation date: 2025-03-05
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chestnut Ridge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0294-2025