Recall Issued for TESTO-200 Testosterone Injection Due to cGMP Violations

The US Food and Drug Administration (FDA) has announced a voluntary recall of TESTO-200 (Testosterone Cypionate Injection, USP, 200mg/mL), distributed in 10mL multidose vials, by Advanced Pharmaceutical Technology, Inc, based in Elmsford, New York. This injectable, prescription-only product is intended for intramuscular administration. A total of 26 vials from lot P-24-1 are affected. The recall is currently ongoing, and no public press release has been issued to date.

The recall was initiated on May 30, 2025, following the firm’s discovery of current Good Manufacturing Practice (cGMP) violations, which may impact the safety or effectiveness of the drug. The recall has not yet been classified by the FDA in terms of risk level. Distribution of the affected product was limited to New York and New Jersey, and notification to consignees was made via formal letters from the firm.

TESTO-200 is commonly prescribed for the treatment of primary hypogonadism and hypogonadotropic hypogonadism, both of which are conditions characterized by testosterone deficiency in males. Testosterone cypionate is a long-acting testosterone ester that helps restore normal testosterone levels, supporting sexual function, mood, muscle mass, and bone density. Pharmacists and health care professionals should remove the affected lot from circulation and monitor updates from the FDA regarding the final classification and further actions.