FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
What this means
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable medication packaged in single-use syringes due to concerns that the product may not be sterile. The issue stems from the use of bacteriostatic water in formulation and potential problems with processing equipment used to compound the product.
- Check if your medication matches one of the affected lot numbers: 07282026@3, 08252026@9, 08042026@12, or 08072026@15.
- Contact your healthcare provider or pharmacy immediately if you have received this medication.
- Do not use the product. Your provider will advise on next steps and alternative treatment options.
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
57.0 mls - in patient specific syringe doses
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2027More Carolina Infusion recalls
- 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 semaglutide/cyanocobalamin 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
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