Carolina Infusion, Llc: Tirzepatide/cyanocobalamin 26/2 Mg/ml Injectable
Recall Summary Carolina Infusion, LLC is recalling injectable syringes containing tirzepatide/cyanocobalamin (a diabetes and weight-loss medication mixed with vitamin B12) distributed nationwide because the company cannot guarantee the products are sterile. The sterility issue stems from the use of bacteriostatic water in the formulation and concerns with the processing equipment used to prepare the injections. This is a Class II recall, meaning there is a potential health risk, though the company has not reported any confirmed injuries.
- Recalling firm
- Carolina Infusion, LLC
- 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
- Reason
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/63d690dd-496f-49d3-a8fd-9cdc3ac9fa49