Notice names this product. Carolina Infusion’s TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE is named in FDA Class II recall D-0027-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Identifying details: Lot:07212026@18, BUD: 9/4/2026; 07222026@14, BUD: 9/5/2026; 07292026@8, BUD: 9/12/2026; 08052026@14, BUD: 9/19/2026; 08142026@1, BUD: 9/28/2026; 08192026@10, BUD: 10/3/2026; 08242026@25, BUD: 10/8/2026; 08282026@2, BUD: 10/12/2026; 08292026@1, BUD:10/13/2026;. Units affected: 297 mL - in patient specific syringe dose. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
TIRZEPATIDE/CYANOCOBALAMIN 26/2 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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Company / brand: Carolina Infusion recalls
Affected product: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE recall status
Official ID D-0027-2027 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.