Quality & complianceOfficial

FDA lists Class II recall of Carolina Infusion compounded tirzepatide/cyanocobalamin injection over sterility concerns

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Carolina Infusion's compounded tirzepatide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded as D-0027-2027, because sterility cannot be assured.

The US Food and Drug Administration has recorded a Class II recall of a compounded injectable combining tirzepatide and cyanocobalamin, supplied by Carolina Infusion, LLC. The product is described as 26/2 mg/ml and is listed under recall number D-0027-2027 in the agency's enforcement report dated 14 October 2026.

The stated reason is a lack of assurance of sterility. The entry points to two issues: the formulation used bacteriostatic water, and the processing equipment used for the compounded product was also implicated. The entry as provided gives no further detail on either point.

The recall is listed as ongoing, with distribution nationwide within the United States. The text available to VigiEye did not include the product's lot numbers, quantities, expiry dates, the date of classification or the firm's recall strategy, so those details cannot be reported here.

For context, the FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

What it means for your team

  • Compounders and outsourcing facilities should review how they qualify diluents such as bacteriostatic water and how they validate processing equipment for sterile products.
  • Pharmacovigilance and quality teams handling compounded GLP-1-type products should check whether any affected product appears in their supply chain or in adverse-event reports.
  • Lot-level and quantity details are not in the item reviewed; teams should consult the full FDA enforcement report entry for D-0027-2027 before taking action.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →