Official recall notice

FDA DrugClass IINotable

Tirzepatide/Cyanocobalamin MG/ML Injectable Recall (Oct 2026)

Product: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Recall date
2026-10-14
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

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Product description

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Affected products

Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;

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