Quality & complianceOfficial

FDA logs Class II recall of compounded tirzepatide/cyanocobalamin injection over sterility assurance 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-0030-2027, due to a lack of assurance of sterility.

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 listed at 85/2 mg/mL and the entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0030-2027.

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

The recall's status is listed as ongoing, and distribution is described as nationwide within the United States. The text available does not give lot numbers, quantities, dates of distribution or details of any reported adverse events, so the scale of the recall cannot be assessed 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

  • Quality teams working with compounders or outsourcing facilities should check that sterility assurance controls cover both formulation components, such as diluents, and processing equipment.
  • Pharmacovigilance teams may wish to review any reports involving compounded tirzepatide products for signs of injection-site or infection-related events, although the entry cites none.
  • Supply chain and distribution teams should confirm whether any product from Carolina Infusion was received, as the recall is nationwide and still ongoing.
  • Lot-level details are not in the available record, so affected parties will need to consult the full FDA enforcement report entry.

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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