Quality & complianceOfficial

FDA lists Class II recall of Carolina Infusion's compounded tirzepatide injection over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The recall of tirzepatide 26 mg/mL injectable, distributed nationwide, cites lack of assurance of sterility linked to bacteriostatic water in the formulation and to processing equipment.

The US Food and Drug Administration has published a Class II recall in its enforcement report for tirzepatide 26 mg/mL injectable, a compounded product from Carolina Infusion, LLC. The entry is dated 14 October 2026 and carries recall number D-0017-2027.

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

The recall is shown as ongoing and covers distribution nationwide within the US. The text available does not give product quantities, lot numbers, expiry dates, the date the recall began or the number of patients or customers affected, and it does not report any adverse events.

By way of context, the FDA uses Class II for 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 sterility assurance controls, including the diluents used in formulations and the equipment used in processing.
  • Pharmacies, clinics and distributors holding this product should check the full FDA enforcement report entry for lot and code details, which are not in the material reviewed here.
  • Pharmacovigilance teams may wish to watch for any reports of infection or injection-site reactions linked to compounded tirzepatide, though none are cited in this listing.

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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