FDA lists sterility recalls of compounded semaglutide and tirzepatide injections

FDA's enforcement report carries a set of Class II recalls dated 14 October 2026 for compounded GLP-1 injections. Carolina Infusion has recalled several strengths of compounded tirzepatide and semaglutide, some combined with cyanocobalamin, supplied in single-use syringes; the stated reason is lack of assurance of sterility linked to the use of bacteriostatic water and to processing equipment. A separate entry covers a compounded tirzepatide multi-dose vial from Apothecary Pharma for the same reason. The recalls are listed as ongoing.

A Class II recall means use could cause temporary or medically reversible harm, or that serious harm is unlikely. It is a product-quality action about these compounded batches, not a finding about semaglutide or tirzepatide themselves.

The practical point is to know what your patients are injecting. Compounded and combination GLP-1 products are not the licensed pens, and their quality depends on the pharmacy that made them.

• Ask patients on a GLP-1 or GIP/GLP-1 agonist whether their supply is a licensed pen or a compounded product.
• Compounded combinations with cyanocobalamin are not licensed formulations; their sterility depends on the compounder.
• In a patient using a compounded injectable, consider injection-site infection or systemic infection when assessing new fever or skin changes.
• Report suspected adverse events from compounded products to the regulator in your country.

Why it matters

Patients often do not distinguish a compounded syringe from a licensed pen, so the prescriber has to ask.

Don't overread it

This is a sterility recall of specific compounded batches, not a safety signal about the drugs themselves.

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