FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
What this means
Carolina Infusion LLC is recalling compounded semaglutide/cyanocobalamin injectable syringes due to lack of assurance of sterility. The issue stems from the use of bacteriostatic water in formulation and concerns about processing equipment. The recall affects five specific lots distributed nationwide.
- If you have received a syringe from Carolina Infusion with a lot number and expiration date matching those listed, do not use it.
- Contact your healthcare provider or pharmacy immediately for guidance.
- Do not dispose of the medication without asking your healthcare provider how to safely discard it.
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
82.9 mls - in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0026-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
- FDA-Drug2026-10-14Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility concerns
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.