FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion tirzepatide/cyanocobalamin injection recalled for sterility assurance issues
What this means
Carolina Infusion, LLC is recalling tirzepatide/cyanocobalamin injectable medication due to lack of assurance of sterility. The issue relates to the formulation process using bacteriostatic water and processing equipment used to compound the product. The affected medication was distributed nationwide in patient-specific syringes.
- Check if you received this injection from Carolina Infusion with a lot number and beyond-use date between 07/21/2026 and 08/29/2026.
- Do not use the recalled medication. Contact your healthcare provider or pharmacy for guidance.
- Return the medication to the pharmacy where you received 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
297 mL - in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
TIRZEPATIDE/CYANOCOBALAMIN 26/2 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-0027-2027More 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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