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

Carolina Infusion's tirzepatide/cyanocobalamin injectable is the subject of an ongoing nationwide US recall, with FDA citing a lack of assurance of sterility.

The US Food and Drug Administration has listed a Class II recall of tirzepatide/cyanocobalamin 64/2 mg/mL injectable, a compounded product from Carolina Infusion, LLC. The recall is recorded in the agency's enforcement report under number D-0028-2027, dated 14 October 2026.

The stated reason is a lack of assurance of sterility. FDA's entry links this to two factors: the formulation, which used bacteriostatic water, and the processing equipment used to make the compounded product.

The recall status is ongoing, and the product was distributed nationwide within the US. The material available does not give quantities, lot numbers, dates of manufacture or details of how the problem was identified, so the scale of the affected supply is unclear.

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

  • Quality teams working with compounders or outsourcing facilities should check that sterility assurance controls cover both formulation components and processing equipment.
  • Pharmacovigilance and medical information teams may wish to be ready for enquiries about compounded tirzepatide products, noting this item does not report any adverse events.
  • Distributors and healthcare providers who handled the product should consult the full FDA enforcement report entry for lot and code details, which are not included in the summary reviewed here.

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 →