FDA Warns 503B Outsourcing Facility ProRx After Sterility Findings and Semaglutide, Tirzepatide Recalls
On April 7, 2026, FDA issued a warning letter to ProRx LLC (Exton, PA), a registered 503B outsourcing facility, citing "Adulterated Drug Products." After a September 2025 inspection, FDA said products failed to meet 503B conditions and noted "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk." The letter acknowledges the firm’s October 2025 voluntary recall of a lot of Tirzepatide Injection 27mg/3mL and various lots of Semaglutide Injection multidose vials for lack of sterility assurance.
What this meansOutsourcing facilities like this one supply compounded GLP-1s to clinics and telehealth programs — checking a facility’s FDA inspection and recall history is a concrete way to vet where a prescription actually comes from.
Source: FDA original ↗