FDAFDA recall D-0030-2027 · Oct 14, 2026
Carolina Infusion, LLC: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE recall
Recall found
Product
TIRZEPATIDE/CYANOCOBALAMIN 85/2 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 for recall
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot:07212026@9, BUD: 9/4/2026; 07252026@2, BUD: 9/8/2026; 08122026@14, BUD: 9/26/2026; 08272026@8, BUD: 10/11/2026; 08312026@18, BUD: 10/15/2026.
- Quantity
- 30.4 mLs - in patient specific syringe dose
- Distribution
- Nationwide within the U.S
- Recalling firm
- Carolina Infusion, LLC, Ridgeland, SC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-10
Source: openFDA enforcement record D-0030-2027 · search recall number D-0030-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.