The FDA enforcement report dated 14 October 2026 lists an ongoing Class II recall of compounded tirzepatide 26 mg/mL injectable, packaged in single-use syringes, from Carolina Infusion, LLC. The stated reason is lack of assurance of sterility, linked to the use of bacteriostatic water in the formulation and to processing equipment. Companion entries from the same firm cover compounded tirzepatide and semaglutide products combined with cyanocobalamin.
A Class II recall means the FDA judges that use may cause temporary or medically reversible harm, or that serious harm is remote. It is a product-quality action on one compounder, not a safety finding about tirzepatide or semaglutide themselves.
The practical point is wider than one firm. Compounded incretin products sit outside the licensed supply chain, and sterility and dose accuracy depend on the compounder. Patients who source these drugs online or from clinics should be asked where their injections come from.
- Ask every patient on an incretin injection where it is sourced — licensed pen, pharmacy, or compounded syringe.
- Check injection sites in anyone using compounded product who reports redness, swelling or fever.
- This recall concerns one US compounder; it says nothing about the licensed branded pens.
- Vitamin B12 'combination' incretin products are compounded preparations, not licensed formulations.
Why it matters
Online and clinic-supplied incretins are common, and the prescriber is often the last to know where the drug came from.
Don't overread it
A sterility-assurance recall at one compounder is not a safety signal for tirzepatide or semaglutide.
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