TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged… was recalled on September 10, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded 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
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.
Units affected: 29.6 mls - in patient specific syringe dose
Where it was sold: Nationwide within the U.S
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Carolina Infusion, LLC
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
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