Drug FDA Class II Ongoing Chemical
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
Strides Pharma, Inc. Published Apr 2, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Strides Pharma, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Presence of foreign substance: Presence of Benzene.
Hazards
Benzene · primary
Affected products (1)
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
TESTOSTERONE · 195,952 Cartons; 30 sachets/Carton.
NDC: 64380-151, 64380-152, 64380-152-01, 64380-152-02, 64380-151-01, 64380-151-02
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
Affected areas
Nationwide
Timeline
- InitiatedMar 5, 2025
- PublishedApr 2, 2025
- Recall number
- D-0293-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.