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New Vitalis Pharmacy, a compounding pharmacy in Louisville, Kentucky, was cited for manufacturing sterile drug products under insanitary conditions that posed patient safety risks, resulting in adulterated products that violated federal manufacturing standards. FDA inspectors identified serious deficiencies in the facility's sterile compounding practices during an August 2021 inspection, leading to the company's voluntary recall of Testosterone Cypionate/Testosterone Propionate products in September 2021 and cessation of all sterile compounding operations. The violations centered on the company's failure to maintain adequate current good manufacturing practice (CGMP) standards required for sterile drug products, which exposed patients to potentially contaminated medications.