The FDA enforcement database lists a Class II recall of compounded tirzepatide 26 mg/mL injection in patient-specific prefilled syringes from Carolina Infusion, a US compounding pharmacy. Related recalls cover tirzepatide and semaglutide combined with cyanocobalamin from the same firm. The reason given is lack of assurance of sterility, tied to the bacteriostatic water used and to processing equipment. The recall is ongoing.
A Class II recall indicates a possibility of temporary or reversible harm, or a remote chance of serious harm. This is a product-quality action on a compounded preparation, not a safety signal for licensed tirzepatide.
For prescribers, the wider point is that compounded and grey-market incretin products sit outside the manufacturing controls of licensed pens, and patients often do not mention where they obtain them.
- Ask patients on tirzepatide or semaglutide where their supply comes from.
- Consider infection or contamination when a patient on a compounded injection has local or systemic inflammation.
- Advise stopping any recalled lot and retaining the packaging.
- Prefer licensed products with traceable batches.
Why it matters
Compounded incretin use is common and largely invisible in the prescription record.
Don't overread it
This is a manufacturing-quality recall of a compounded product, not a finding about the licensed drug.
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