FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility assurance failure
What this means
Carolina Infusion, LLC has recalled compounded tirzepatide/cyanocobalamin injectable syringes due to lack of assurance of sterility. The issue stems from the use of bacteriostatic water in formulation and concerns with processing equipment. The affected product was distributed nationwide in patient-specific single-use syringes.
- Check if you have received an injection from Carolina Infusion with lot numbers 07252026@3, 08112026@5, 08212026@21, or 08282026@3
- Do not use the product if you have it
- Contact Carolina Infusion or your healthcare provider for guidance on safe disposal and 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
29.6 mls - in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
TIRZEPATIDE/CYANOCOBALAMIN 64/2 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-0028-2027More 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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