D-0294-2025 Class II
FDA drug recall D-0294-2025 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: 244,412 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
- 244,412 Cartons; 30 sachets /Carton
Product Description
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 Pattern
Nationwide in the U.S
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0294-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026