The FDA enforcement database lists a Class II recall, dated 14 October 2026, of compounded semaglutide 3 mg/mL in prefilled syringes from Carolina Infusion, LLC, part of a wider recall of its compounded GLP-1 products. The reason given is lack of assurance of sterility, related to the use of bacteriostatic water and to processing equipment. The recall is ongoing.
Compounded products do not go through the approval process that licensed pens do, and their sterility, strength and stability are not independently verified. Dosing by volume from a syringe also invites errors, because concentrations vary between compounders.
These products are US-specific, but compounded and unlicensed incretin injections circulate widely.
- Ask patients on semaglutide or tirzepatide whether they use a licensed pen or a compounded product
- Check the stated concentration and dose of any compounded product to avoid volume-based dosing errors
- Examine injection sites in patients using compounded products
- Report suspected adverse events from compounded products to the pharmacovigilance programme
Why it matters
Unlicensed incretin supply is a real source of harm that prescribers rarely ask about.
Don't overread it
This recall concerns one compounding pharmacy's products, not licensed semaglutide.
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