Quality & complianceOfficial

FDA lists Class II recall of Carolina Infusion's compounded semaglutide injection over sterility concerns

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Recall D-0018-2027 covers semaglutide 3 mg/mL injectable from Carolina Infusion, LLC, with FDA citing a lack of assurance of sterility; the recall is ongoing nationwide.

The US Food and Drug Administration has published a Class II drug recall for semaglutide 3 mg/mL injectable, made by Carolina Infusion, LLC. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0018-2027.

FDA gives the reason for recall as a lack of assurance of sterility. The listing links this to two issues: the formulation used bacteriostatic water, and the processing equipment used for the compounded product.

The recall is recorded as ongoing, and distribution is nationwide within the United States. The text available for this item does not include product quantities, lot numbers, expiry dates, the recall initiation date or the level to which the product was recalled, and no reports of adverse events are given.

Under FDA's classification system, a Class II recall covers situations in which 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 used in sterile formulations, and whether processing equipment is suitable for the product.
  • Pharmacovigilance and quality teams that handle compounded GLP-1 products should check whether any affected semaglutide 3 mg/mL stock is in their supply chain and follow FDA's recall record for further detail.
  • Distributors and healthcare providers should look to the full FDA enforcement entry for batch-level information, which is not in the text 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.

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