Carolina Infusion, Llc: Semaglutide/cyanocobalamin 3/2 Mg/ml Injectable
Recall Summary Carolina Infusion, LLC is recalling injectable semaglutide/cyanocobalamin (a combination medication) distributed nationwide because the company cannot guarantee the product is sterile. The sterility concern is related to the use of bacteriostatic water in the formulation and issues with the processing equipment used to make the compounded product. This is a Class II recall affecting patients across all U.S. states who received this medication in single-use syringes from this company.
- Recalling firm
- Carolina Infusion, LLC
- Product
- SEMAGLUTIDE/CYANOCOBALAMIN 3/2 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/9f1aaeca-7a2c-4b80-832b-114753c12884