FDA Warns Thrive Health Solutions Over Sterility Failures and Unapproved Tirzepatide Injection Product
On February 9, 2026, FDA issued a warning letter to Thrive Health and Wellness, LLC dba Thrive Health Solutions (Englewood, CO), citing "Adulterated Drug Products" after a March–April 2025 inspection found "serious deficiencies in your practices for producing drug products intended or expected to be sterile." FDA identified repackaged products, including "MEGALean (Tirzepatide/Cyanocobalamin) Injections," as unapproved new drugs. The letter acknowledges the firm ceased repackaging sterile products and recalled all repackaged sterile drug products dispensed January 2 through April 18, 2025.
What this meansBranded blends like a tirzepatide-plus-B12 injectable are not FDA-approved products — sterility findings at the firms behind them are exactly why vetting the pharmacy or facility that handles your medication matters.
Source: FDA original ↗