Quality & complianceOfficial

FDA logs Class II recall of Carolina Infusion compounded semaglutide/cyanocobalamin injection over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Carolina Infusion's compounded semaglutide and cyanocobalamin injectable is subject to an ongoing nationwide US recall, recorded in the FDA enforcement report under number D-0019-2027.

The US Food and Drug Administration has classified a Class II recall of semaglutide/cyanocobalamin 3/2 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-0019-2027.

The stated reason is lack of assurance of sterility. The record links this to two issues: the formulation used bacteriostatic water, and the processing equipment used for the compounded product was also a concern.

The recall is listed as ongoing, with distribution nationwide within the US. The material available does not give lot numbers, quantities, dates of manufacture or the date the recall began, and it does not report any adverse events.

For context, the FDA applies 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

  • Compounding pharmacies and outsourcing facilities should review sterile-processing equipment and diluent choices, including use of bacteriostatic water, against the reasons cited in this recall.
  • Pharmacovigilance teams monitoring compounded GLP-1 products may wish to check for reports linked to this product, though the source gives no adverse event information.
  • Quality and supply-chain teams should note that lot-level details are not in the source and would need to be confirmed from the full enforcement report record.

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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