FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion tirzepatide injectable recalled for sterility concerns
What this means
Carolina Infusion LLC is recalling tirzepatide 26 mg/mL injectable syringes due to concerns that the product may not be sterile. The issue is related to the use of bacteriostatic water in formulation and processing equipment used to compound the product. The recall affects specific lot numbers distributed nationwide.
- Check if you have a syringe from one of the affected lots (09012026@3, 08032026@16, 08052026@8, or 08072026@13) with a beyond-use date of September 17–21, 2026 or October 16, 2026.
- Do not use the product if you have an affected lot.
- Contact your pharmacy or healthcare provider for a replacement or guidance.
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
5.6 mLs - in patient specific syringe doses
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
TIRZEPATIDE 26 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-0017-2027More 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/cyanocobalamin injectable recalled for sterility concerns
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