D-0293-2025 Class II
FDA drug recall D-0293-2025 was initiated by Strides Pharma, Inc. on Mar 5, 2025 and is designated Class II. Reason for recall: Presence of foreign substance: Presence of Benzene. Affected quantity: 195,952 Cartons; 30 sachets/Carton.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 2, 2025
- Initiation Date
- Mar 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 195,952 Cartons; 30 sachets/Carton.
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.
Distribution Pattern
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0293-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026