Quality & complianceOfficial

FDA classes Carolina Infusion sermorelin injection recall as Class II over sterility assurance concerns

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The Class II recall of compounded sermorelin acetate 1 mg/ml injectable cites formulation with bacteriostatic water and processing equipment, and remains ongoing across the US.

The US Food and Drug Administration has listed a Class II recall of sermorelin acetate 1 mg/ml injectable, a compounded product from Carolina Infusion, LLC, in its enforcement report dated 14 October 2026. The recall is numbered D-0020-2027.

The reason given is lack of assurance of sterility. The entry points to two issues: the formulation using bacteriostatic water, and the processing equipment used for the compounded product.

The recall status is ongoing. According to the report, the product was distributed nationwide within the United States.

The text available for this item does not include the number of units affected, lot numbers, expiry dates, the recall initiation date or the level of the recall. It also does not report adverse events linked to the product. 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 how bacteriostatic water is used in formulations and whether equipment used in processing supports sterility assurance.
  • Quality teams should check the full FDA enforcement report entry for lot and code details before assessing any exposure, as these are not in the text available here.
  • Pharmacovigilance teams handling compounded injectables may wish to watch for sterility-related adverse event reports involving this product.

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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