The FDA enforcement database lists Class II recalls of compounded tirzepatide/cyanocobalamin injections (85/2 and 76/2 mg/mL) and a semaglutide/cyanocobalamin injection (3/2 mg/mL) made by Carolina Infusion, a US compounder. The stated reason is lack of assurance of sterility, linked to the bacteriostatic water used in formulation and to the processing equipment. The recall was posted on 14 October and is listed as ongoing.
A Class II recall means the product may cause temporary or reversible harm, with serious harm considered remote. These are not the licensed branded products, and the action says nothing about the safety of tirzepatide or semaglutide themselves.
Compounded incretin injections, often combined with vitamins, have spread with demand for weight loss. Patients rarely volunteer that their pen came from a compounder or an online clinic.
- Ask patients on an injectable GLP-1 or tirzepatide where it is dispensed from and whether it is combined with a vitamin.
- Examine injection sites in anyone using a compounded product who reports local redness, swelling or fever.
- Report suspected infections from compounded injections to the relevant pharmacovigilance programme.
- This recall concerns US-dispensed products; their availability in India is not established.
Why it matters
Patients sourcing weight-loss injections outside licensed supply carry risks their prescriber may not know about.
Don't overread it
A sterility recall of one compounder's products is not a safety finding about the licensed drugs.
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