Recall Underscores the Importance of Verified, Compliant Manufacturing
In March 2025, the U.S. Food and Drug Administration (FDA) issued an amended (essentially a second warning letter) Form 483 to ProRX following an inspection in 2024 that identified multiple deficiencies in quality-control procedures, production and processing.
Read the original 483 HERE:
Read the amended 483 HERE:
Then, in October 2025, ProRX initiated a voluntary recall of multiple lots sterile compounded drugs, including Tirzepatide, citing an inability to ensure sterility for thousands of vials.
See the official FDA recall notice HERE:
While voluntary recalls are important for patient safety, these events emphasize how crucial it is to partner with pharmacies and manufacturers that maintain continuous FDA compliance and validated sterile compounding practices.
At BlueVaseRX, all Tirzepatide formulations are produced in partnership with BPI Labs, an FDA-registered and cGMP-compliant drug manufacturer. Every batch is rigorously tested for potency, purity, and sterility, with full Certificates of Analysis available upon request.
Our mission is to support companies, prescribers, and patients with safe, compliant, and transparent access to Tirzepatide and other compounded medications.
Why companies trust BlueVaseRX:
Manufactured exclusively in FDA-registered facilities
Full COA and sterility documentation for every batch
Consistent nationwide fulfillment
Dedicated support team
If your company or patients were impacted by the recent ProRX recall, we’re here to help ensure a smooth transition to a compliant and verified supply source.
