Carolina Infusion, Llc: Tirzepatide/cyanocobalamin 64/2 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 product is sterile. The sterility concern stems from the use of bacteriostatic water in formulation and issues with the processing equipment used to prepare the drug.
- Recalling firm
- Carolina Infusion, LLC
- Product
- TIRZEPATIDE/CYANOCOBALAMIN 64/2 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/efdcae1d-94ad-4882-a036-5ddbc7a55ff4