Drugs and FDA

Carolina Infusion recalls compounded semaglutide and tirzepatide products over sterility concerns

The FDA lists 11 Carolina Infusion products, including semaglutide and tirzepatide, in an ongoing Class II recall over sterility concerns.

Reported by 1 outlet Saturday, October 10, 2026

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FDA records say Carolina Infusion is recalling 11 compounded drug products in an ongoing Class II recall. The recall was reported 2026-10-08 and includes injectable semaglutide and tirzepatide products, both alone and combined with cyanocobalamin.

The recalled products also include sermorelin acetate and two Tri-Mix formulations. The FDA cited a lack of assurance of sterility related to formulation using bacteriostic water and processing equipment used in the compounded products. The records do not describe further steps in the recall.

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