Quality & complianceOfficial

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

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The US regulator's enforcement report records an ongoing recall of Sterile Lubricant Dry Eye Relief Eye Drops, distributed nationwide, citing lack of assurance of sterility.

The US Food and Drug Administration has classified a recall of Sterile Lubricant Dry Eye Relief Eye Drops, made by K.C. Pharmaceuticals, Inc., as Class II. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0006-2027.

The stated reason for the recall is lack of assurance of sterility. The recall status is listed as ongoing, and the product was distributed nationwide across the United States.

The text available for this item is limited to the headline details and the recall metadata. It does not give lot numbers, expiry dates, quantities, the date the firm began the recall, or any reports of adverse events or contamination, so those details cannot be confirmed here.

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

  • Quality teams should note that sterility-assurance failures in ophthalmic products continue to prompt enforcement action, even when the recall is classed as Class II.
  • Distributors, pharmacies and retailers in the US should check the full FDA enforcement report entry for lot and code information, which is not given in the summary.
  • Pharmacovigilance teams may wish to review any complaints or adverse event reports on eye drops against the recall details once these are verified.

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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