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Class II · ModerateActive recall

TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot:08032026@23, BUD: 9/17/2026; 08172026@19, BUD: 10/1/2026; 08262026@13, BUD: 10/10/2026.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forCarolina Infusion, LLC
Show the full FDA record
Full product labelTIRZEPATIDE/CYANOCOBALAMIN 76/2 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
Recalling firmCarolina Infusion, LLC
DistributionNationwide within the U.S
Quantity24.8 mLs -in patient specific syringe dose
Recall initiated2026-09-10
Report date2026-10-14
Recall completed—
Recall numberD-0029-2027
ClassificationClass II
FDA statusOngoing
Origin on fileRidgeland SC United States

Related

Tirzepatide recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.