Testosterone Cypionate Injection Recalled Due to Crystallization Concerns

Eugia US LLC has voluntarily recalled 36 816 vials of testosterone cypionate injection, USP, CIII, 200 mg/mL, distributed in 1 mL single-dose vials (NDC 55150-277-01). This recall, classified as Class II by the US Food and Drug Administration (FDA), affects Lot #1TC24075A with an expiration date of 11/30/2026. The product was distributed nationwide in the United States and was manufactured by Eugia Specialties Limited in Telangana State, India. The recall was initiated on April 10, 2025.

According to the FDA Enforcement Report, the recall was prompted by complaints that crystals in the solution were not redissolving despite warming and shaking the vials—an issue that raises concerns about the product’s quality and compliance with current good manufacturing practices (cGMP). While no press release has been issued, notification to consignees was made via letter. The recall remains ongoing.

Testosterone cypionate injection is a Schedule III controlled substance indicated for testosterone replacement therapy in males with conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism. Pharmacists should ensure affected stock is removed from inventory and follow the manufacturer’s instructions for returning the product.