Strides Pharma Inc. has issued a voluntary recall of its Testosterone Gel 1% products in both the United States and Canada due to the detection of trace amounts of benzene, a known human carcinogen, in certain lots. The recall affects both 2.5-gram and 5-gram unit-dose packets, widely used in gender-affirming hormone therapy for transgender men and some transgender women.
The U.S. Food and Drug Administration (FDA) has classified the recall as Class II, meaning use of the affected product may cause temporary or medically reversible health issues, though the risk of serious harm is considered remote. Benzene exposure, even at low levels, is linked to blood disorders and cancers like leukemia.
The recall covers:
- 195,952 cartons of the 2.5-gram gel (NDC 64380-151-02), shipped in cartons containing 30 sachets each
- 244,412 cartons of the 5-gram gel (NDC 64380-152-02), also in cartons of 30 sachets
- Products with expiration dates ranging from March 2025 to January 2027
- Distributed nationwide in the U.S. and to pharmacies and wholesalers in Canada between May 31, 2023, and February 20, 2025
While no adverse events have been reported, and topical use is not expected to result in toxic effects, both the FDA and the Canadian Board of Pharmacy are urging healthcare providers and patients to check their supply for affected lot numbers.
You can review the full recall alert for Canada here: Testosterone Gel 1% Recall Notice (Canada)
The recall is also registered with the FDA under Event ID 96412, though no public press release has been issued.
This medication is commonly prescribed for testosterone replacement therapy, including for cisgender men with primary or hypogonadotropic hypogonadism, and for transgender men and women as part of medical transition. If you’re using Testosterone Gel 1%, check the lot number on your packaging. Affected patients are advised to discontinue use immediately and speak with their pharmacist or prescribing provider for alternatives or replacements.
Affected Lot Numbers
Testosterone Gel 1% 2.5 grams (NDC 64380-151-02):
5501127A, 5501236A, 5501341A, 5501406A, 5501408A, 5501516A, 5501568A, 5501829A, 5502000A, 5502004A, 5502005A, 5502092A, 5502217A, 5502262A
Testosterone Gel 1% 5 grams (NDC 64380-152-02):
5501103A, 5501237A, 5501238A, 5501278A, 5501280A, 5501342A, 5501372A, 5501496A, 5501499A, 5501580A, 5501582A, 5501653A, 5501656A, 5501770A, 5501842A, 5501868A, 5501882A, 5501957A, 5502001A, 5502033A, 5502112A, 5502115A, 5502180A, 5502181A
Pharmacists are encouraged to review inventory and follow standard recall protocols, including returning affected lots to the manufacturer. Patients who have questions or need support should contact their provider or pharmacy. If you experience symptoms or have concerns about past exposure, report them to the FDA’s MedWatch program at https://www.fda.gov/medwatch.
At TransVitae, we understand how crucial safe, uninterrupted access to hormone therapy is for our community. If you’re affected by this recall, know that you are not alone, and support is available to help navigate the next steps safely.
