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.

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.

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.