Quality & complianceOfficial

FDA logs Class II recall of Carolina Infusion's compounded tirzepatide/cyanocobalamin injectable over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The compounded injectable is recalled nationwide in the US after the FDA cited a lack of assurance of sterility linked to bacteriostatic water and processing equipment.

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 entry, dated 14 October 2026, carries recall number D-0029-2027.

The product is listed as TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE. The stated reason is a lack of assurance of sterility, which the enforcement report ties to two issues: the formulation's use of bacteriostatic water, and the processing equipment used in the compounded product.

The recall is shown as ongoing, with distribution nationwide within the US. The text available for this item does not include lot numbers, quantities, dates of manufacture or any reports of adverse events, so the scale of the recall and any patient impact cannot be gauged from it.

For context, the FDA defines a Class II recall as one involving a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Compounding pharmacies and outsourcing facilities should review how bacteriostatic water and processing equipment are controlled in sterile preparations, as both are cited here.
  • Quality teams should note that sterility assurance failures can arise from formulation components as well as equipment, not only from aseptic technique.
  • Pharmacovigilance and supply-chain teams handling compounded GLP-1-type products should check whether any affected product has been received, and watch the FDA enforcement report for lot-level detail.
  • The recall is ongoing, so further information may follow.

Official source: FDA enforcement report ↗

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

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