Official recall notice
FDA DrugClass IINotable
Tirzepatide /ML Injectable Recall (Oct 2026) – Carolina Infusion
Product: TIRZEPATIDE 26 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.
Product description
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Affected products
Lots: 09012026@3, BUD: 10/16/2026; 08032026@16, BUD: 9/17/2026; 08052026@8, BUD: 9/19/2026; 08072026@13, BUD: 9/21/2026.