Carolina Infusion, LLC recalls TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE
- Recalling company
- Carolina Infusion, LLC
- Product
- 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
- Reason
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 10, 2026
- Reported
- Oct 14, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 29.6 mls - in patient specific syringe dose
- Lot / codes
- Lot:07252026@3, BUD: 9/8/2026; 08112026@5, BUD: 9/25/2026; 08212026@21, BUD: 10/5/2026; 08282026@3, BUD: 10/12/2026.
- Company location
- Ridgeland, SC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0028-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0028-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.