FDA Enforcement Report Lists Sterility Recalls of Compounded Tirzepatide, Semaglutide, B12 Blends, and Sermorelin From Two Carolina Compounders
FDA's October 14, 2026 enforcement report lists 18 Class II recall entries, classified October 8, for compounded injectables for lack of assurance of sterility. Apothecary Pharma of Cary, North Carolina recalled 22 multi-dose vials of tirzepatide 18 mg/mL and one NAD+ vial distributed nationwide, starting September 24; Carolina Infusion of Ridgeland, South Carolina recalled patient-specific syringes of tirzepatide, tirzepatide and semaglutide blended with cyanocobalamin (vitamin B12), semaglutide, sermorelin, and erectile-dysfunction mixes, citing processing equipment and, for some products, a formulation using bacteriostatic water. Fox station coverage on October 21 noted that no illnesses or injuries were reported and that FDA had sent Apothecary Pharma a warning letter in December 2025 over sterile manufacturing practices, without linking it to the recall.