The FDA enforcement report, dated 14 October, lists Class II recalls of compounded injectable tirzepatide/cyanocobalamin (64/2 and 76/2 mg/mL) and semaglutide/cyanocobalamin (3/2 mg/mL) dispensed in single-use syringes by one US compounding pharmacy, Carolina Infusion. The stated reason is lack of assurance of sterility, related to the bacteriostatic water used in formulation and to processing equipment. The recall is listed as ongoing.
Class II means use may cause temporary or medically reversible harm, or that serious harm is unlikely. This is a quality action on specific compounded products, not a finding about tirzepatide or semaglutide themselves.
The practical point is wider than one pharmacy. Compounded and blended incretin products sit outside the approval pathway for the licensed pens, and patients sourcing them online or from wellness clinics may not volunteer it. CDSCO has not commented; the products named are US-dispensed.
- Ask patients on GLP-1 or tirzepatide therapy where their supply comes from, including online and clinic sources.
- Injection-site redness, swelling or fever in someone using a compounded incretin warrants assessment for local or systemic infection.
- Vitamin B12 'blends' are a marketing feature of compounded products, not a licensed formulation.
- Report suspected adverse events from non-licensed products through the national pharmacovigilance programme.
Why it matters
Compounded incretins are a parallel supply chain that sterility failures reach before a prescriber hears about them.
Don't overread it
A sterility recall of one pharmacy's compounded products says nothing about the safety of licensed tirzepatide or semaglutide.
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