Carolina Infusion, Llc: Semaglutide 3 Mg/ml Injectable, 8 X 0

Recall Summary Carolina Infusion, LLC is recalling Semaglutide 3 mg/mL Injectable (8 syringes per package) distributed nationwide because the company cannot guarantee the product is sterile due to issues with the bacteriostatic water used in the formulation and the processing equipment. This is a Class II recall affecting customers in all U.S. states and Washington, D.C.

Recalling firm
Carolina Infusion, LLC
Product
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, 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/f7dab3a6-d693-486e-a9b3-21bcb37ae5b1