The FDA enforcement database lists Class II recalls, dated 14 October 2026, of compounded tirzepatide/cyanocobalamin and semaglutide/cyanocobalamin injections prepared in single-use syringes by Carolina Infusion, LLC. The stated reason is lack of assurance of sterility, linked to the use of bacteriostatic water and to processing equipment. Separate Class II entries cover a compounded tirzepatide multi-dose vial from another US pharmacy for the same reason. The recalls are ongoing.
A Class II recall means use could cause temporary or medically reversible harm, or that serious harm is remote. These are US products, and nothing suggests they reached India. The wider point is that compounded and grey-market incretin injections are common, and patients rarely volunteer where theirs come from.
- Ask every patient on a GLP-1 or dual agonist injection whether it is a licensed pen or a compounded or online product
- Check injection sites for redness, swelling or abscess in anyone using compounded injections
- Report suspected infections from compounded products to the national pharmacovigilance programme
- Do not assume a vitamin B12 combination is a recognised formulation
Why it matters
Demand for incretin drugs has created a parallel supply whose sterility nobody is checking.
Don't overread it
These are US recalls from named pharmacies; they say nothing about the licensed branded products.
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