Strides Pharma Issues Voluntary Nationwide Recall of Testosterone Gel Due to Benzene Contamination

Strides Pharma Inc. has initiated a voluntary Class II recall of 2 testosterone gel products—Testosterone Gel 1% in 2.5-gram and 5-gram unit-dose packets—due to the presence of benzene, a known human carcinogen. The affected 2.5-gram product (NDC 64380-151-02) was distributed in cartons containing 30 sachets, totaling 195 952 cartons. Similarly, 244 412 cartons of the 5-gram product (NDC 64380-152-02) are included in the recall. The recalled lots, which carry expiration dates ranging from March 2025 to January 2027, were distributed nationwide across the US.

The recall, classified as Class II by the US Food and Drug Administration (FDA), was voluntarily initiated by the firm on March 5, 2025, and is currently ongoing. Strides Pharma notified consignees through formal letters. While no public press release has been issued, the recall is recorded under Event ID 96412 in the FDA’s database. Class II recalls are issued when product exposure may cause temporary or medically reversible adverse health consequences or when the probability of serious harm is remote. Benzene exposure is particularly concerning due to its association with blood disorders and cancers such as leukemia.

Testosterone Gel 1% is an androgen replacement therapy prescribed for adult males with conditions linked to a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Pharmacists are advised to check their inventories for the affected lots and follow standard procedures for handling and returning recalled products to ensure patient safety.