FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion tirzepatide/cyanocobalamin injectable recalled for sterility concerns
What this means
Carolina Infusion, LLC has recalled tirzepatide/cyanocobalamin injectable syringes due to concerns that the sterility of the product cannot be assured. The issue is related to the use of bacteriostatic water in the formulation and processing equipment used to prepare the compounded medication. Three specific lots distributed nationwide are affected.
- If you have received this medication, contact your prescriber or healthcare provider immediately.
- Do not use the affected lots: 08032026@23 (BUD 9/17/2026), 08172026@19 (BUD 10/1/2026), or 08262026@13 (BUD 10/10/2026).
- Return any unused syringes to your pharmacy or healthcare provider.
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
24.8 mLs -in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
TIRZEPATIDE/CYANOCOBALAMIN 76/2 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-0029-2027More 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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