Empower Pharmacy Recalls Testosterone Cypionate Injection Over Sterility Concerns

Empower Pharmacy has issued a voluntary nationwide recall of its compounded Testosterone Cypionate Injection of 200 mg/mL due to a lack of assurance of sterility. The product, distributed in 5 mL sterile multiple-dose vials, was compounded on August 20, 2024, and bears a beyond-use date of May 28, 2025. A total of 8230 vials from lot number 202364 are affected. The recall, initiated on May 2, 2025, is currently ongoing and was communicated to consignees via email. No press release has been issued at this time.

The US Food and Drug Administration (FDA) has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is remote. The primary concern is the lack of sterility assurance, a critical quality for injectable medications. Compounded sterile products that are not sterile can pose serious health risks, including infections that could be life-threatening if administered.

Testosterone Cypionate Injection is a Schedule III controlled substance commonly prescribed as hormone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. This includes primary hypogonadism and hypogonadotropic hypogonadism. Pharmacists should check their inventories for lot 202364 and follow proper procedures for returning affected vials to ensure patient safety.