The FDA enforcement report lists an ongoing Class II recall of compounded tirzepatide/cyanocobalamin injection in single-use syringes from a US compounding firm, citing lack of sterility assurance related to the formulation with bacteriostatic water and processing equipment. Related semaglutide products from the same firm are also listed.
This concerns compounded products, not licensed tirzepatide. For prescribers, the practical point is that combination compounded products — here with vitamin B12 added — are outside the licensed formulation and carry quality risks.
- This recall concerns compounded tirzepatide, not the licensed product
- Ask patients where their incretin injections come from
- Advise against compounded combination products with added vitamins
- Report suspected injection-site infections linked to compounded products
Why it matters
Demand for incretins has created a grey market that prescribers rarely see.
Don't overread it
This is a quality recall of a compounder's products, not a safety finding about tirzepatide.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for clinical pharmacology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free