Carolina Infusion, Llc: Tirzepatide 26 Mg/ml Injectable
Recall Summary Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable, a compounded medication dispensed in single-use syringes, distributed nationwide across all U.S. states and territories. The recall was issued because the company cannot confirm the product's sterility due to issues with the bacteriostatic water used in formulation and the processing equipment. This is a Class II recall, affecting patients who received this medication from Carolina Infusion, LLC.
- Recalling firm
- Carolina Infusion, LLC
- Product
- 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;
- Reason
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3edb8c77-85fe-4d46-8031-a1a200d4385d