The FDA enforcement database lists a Class II recall of compounded semaglutide 3 mg/mL injection, supplied as 0.1 mL syringes by Carolina Infusion, a US compounder. The reason given is lack of assurance of sterility, linked to the bacteriostatic water used and to processing equipment. The recall was posted on 14 October and is ongoing; the same firm's compounded tirzepatide and semaglutide combinations with cyanocobalamin are also recalled.
A Class II recall indicates a product that may cause temporary or reversible harm, with serious harm considered remote. It concerns a compounded product, not the licensed semaglutide formulations.
- Ask patients on semaglutide whether their supply is a licensed pen or a compounded syringe.
- Report suspected injection-site infections from compounded products to pharmacovigilance.
- Note that compounded products may differ in concentration and excipients from licensed ones.
- This recall concerns US-dispensed products; availability in India is not established.
Why it matters
Compounded incretins sit outside the quality controls of licensed products, and patients rarely mention them.
Don't overread it
This is a sterility recall of a compounded product, not a safety finding about semaglutide.
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