Quality & complianceOfficial

FDA lists Class II recall of Carolina Infusion compounded semaglutide/cyanocobalamin injectable over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The recall, numbered D-0026-2027 and still ongoing, concerns a compounded injectable and covers nationwide distribution within the US.

The US Food and Drug Administration has recorded a Class II recall of semaglutide/cyanocobalamin 9/2 mg/ml injectable, a compounded product from Carolina Infusion, LLC. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0026-2027.

The stated reason is a lack of assurance of sterility. The report ties this to two issues: the formulation's use of bacteriostatic water, and the processing equipment used to make the compounded product.

The recall is listed as ongoing, and distribution is nationwide within the US. The text available for this item consisted largely of the enforcement report's search-page navigation, so it does not set out details such as lot numbers, quantities, dates of manufacture or the number of units affected.

As context, 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 harm is remote.

What it means for your team

  • Compounders and outsourcing facilities should review how diluents such as bacteriostatic water are chosen and justified in sterile formulations.
  • Quality teams should check that equipment used for sterile compounding is suitable and appropriately controlled, given the processing-equipment issue cited.
  • Pharmacovigilance and supply-chain teams handling compounded GLP-1 products should check whether any affected product has reached their customers or patients, as detailed lot data was not available in the source.

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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