Recall archive / FDA drug enforcement

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East ... — FDA record D-0293-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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: Presence of foreign substance: Presence of Benzene.
Classification: Class II
Recalling firm: Strides Pharma, Inc.
Quantity: 195,952 Cartons; 30 sachets/Carton.
Agency-reported status: Ongoing
Source record identifier: D-0293-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the U.S

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 2, 2025
Recall initiation date: Mar 5, 2025
Center classification date: Mar 25, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.