FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility concerns
What this means
Carolina Infusion, LLC has recalled compounded tirzepatide/cyanocobalamin injectable syringes due to concerns that the product may not be sterile. The issue stems from the use of bacteriostatic water in formulation and potential contamination risks related to processing equipment. The affected syringes were distributed nationwide.
- Check if you have a syringe from the affected lot numbers (07212026@9, 07252026@2, 08122026@14, 08272026@8, or 08312026@18).
- Do not use the product if you have one of the affected lots.
- Contact your prescriber or pharmacy to confirm whether your syringe is affected and discuss next steps.
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
30.4 mLs - in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
TIRZEPATIDE/CYANOCOBALAMIN 85/2 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-0030-2027More 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 semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
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