Quality & complianceOfficial

FDA classifies K.C. Pharmaceuticals artificial tears recall as Class II over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Polyvinyl alcohol 0.5% lubricant eye drops from K.C. Pharmaceuticals are subject to an ongoing nationwide US recall for lack of assurance of sterility.

The US Food and Drug Administration has listed a Class II recall of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%) made by K.C. Pharmaceuticals, Inc. The entry appears in the agency's enforcement report dated 14 October 2026.

The recall number is D-0002-2027, and the stated reason is lack of assurance of sterility. The recall status is ongoing, and the product was distributed across the United States nationwide.

The enforcement report page supplied for this article contained mainly search and navigation text. It did not include details such as lot numbers, expiry dates, quantities, the date the recall began or any reports of adverse events, so those points are not covered here.

As context, the FDA assigns a Class II classification 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 K.C. Pharmaceuticals should check the full recall record on the FDA enforcement report for affected lots and instructions.
  • Pharmacovigilance teams may wish to review any complaints or adverse event reports involving the named eye drops, particularly eye infections or irritation.
  • Sterility assurance failures in ophthalmic products remain a focus area for inspection readiness and supplier oversight.

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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