Androgen Injection Recalled

A labeling error has prompted Sun Pharmaceutical Industries Ltd to voluntarily recall 36,275 cartons of testosterone cypionate injection, according to the February 3, 2021, US Food and Drug Administration (FDA) Enforcement Report. The lot number on the product’s secondary packing is incorrect.  

The recall affects testosterone cypionate injection, 200 mg/mL, 1-mL single-dose vials (NDC 62756-015-40) for intramuscular use from lot JKX2553A. The vials were distributed throughout the United States. 

Sun Pharmaceutical Industries initiated the recall January 11, 2021. On January 24, 2021, the FDA designated the recall Class III. The use of products affected by a Class III recall is not likely to cause harm. 

Testosterone cypionate is a prescription injection for men and adolescent boys who do not make enough testosterone. The drug can also treat certain types of breast cancer in women.

—Jolynn Tumolo