Strides Pharma initiates Class-II recall of Testosterone Gel in US

The recall was voluntarily initiated by Strides Pharma on March 5, 2025, and remains ongoing. Consignees have been informed about this recall formerly, although public press release has not been issue

According to the news agency PTI, Strides Pharma, Inc. has decided to recall over 440,000 cartons of Testosterone Gel in the US following the detection of a carcinogenic foreign substance - benzene - in its product. According to a report from the US Food and Drug Administration (USFDA), the recall, which was initiated on March 5, includes 195,952 cartons of Testosterone Gel (1 per cent) in 2.5 gram quantity, and 244,412 cartons of Testosterone Gel (1 per cent) of 5 gm quantity.

 

However, the recall only applies to products which are manufactured by the Chestnut Ridge, NY-based firm, which is part of Bengaluru-based Strides Pharma Science.

 

 

What is Testosterone Gel?

 

Testosterone Gel 1% is used as an androgen replacement therapy for adult men who have a condition that is linked to a deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism.

 

What is a Class-II recall?

 

A Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

 

According to a report published in HMP Global Learning Network, in the lot which has been affected, 2.5-gram product sachets (NDC 64380-151-02) were distributed in cartons, each containing 30 sachets. Similarly, 244,412 cartons of the 5-gram product (NDC 64380-152-02) are included in the recall. The expiry dates of the recalled lot range from March 2025 to January 2027. 

Reason for recall

 

The recall was voluntarily initiated by Strides Pharma on March 5, 2025. Consignees have been informed about this recall formerly, although a public press release has not yet been issued. The FDA has registered this recall as Event ID 96412 in its database. 

The reason behind the recall is the significant concern of benzene exposure and its link to blood disorders and cancers, including leukemia. Therefore, the USFDA has classified this as a Class-II recall. 

 

Pharmacists have been asked to check their inventories for the affected lots with said batch of the drug following standard procedures for handling and returning the recalled products ensuring safety of the patients.