Quality & complianceOfficial

FDA lists Class II recall of K.C. Pharmaceuticals lubricating eye drops over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The agency's enforcement report records an ongoing nationwide recall of Sterile High Performance Ultra Lubricating Eye Drops, citing lack of assurance of sterility.

The US Food and Drug Administration has published a Class II drug recall for Sterile High Performance Ultra Lubricating Eye Drops, a polyethylene glycol 400 product from K.C. Pharmaceuticals, Inc. The entry appears in the agency's enforcement report dated 14 October 2026.

The recall is numbered D-0009-2027 and the stated reason is lack of assurance of sterility. The record shows the recall as ongoing, and distribution is listed as US nationwide.

The material available for this item does not give lot numbers, expiry dates, quantities, the date the recall began, or details of what prompted the sterility concern. It also does not say whether any adverse events have been reported. Those details would normally sit in the full enforcement report record.

As context, the 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 with ophthalmic products or contract-manufacturing links to the firm should check the full enforcement record for lot and code information.
  • Pharmacovigilance teams may wish to watch for any eye-related adverse event reports tied to the product.
  • Regulatory and compliance staff should note that the recall status is ongoing, so the entry may be updated.

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 →