Quality & complianceOfficial

FDA lists Class II recall of Sterile Eye Drops Advanced Relief over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

K.C. Pharmaceuticals' eye drops are subject to an ongoing nationwide US recall, classified Class II, for lack of assurance of sterility.

The US Food and Drug Administration has published in its enforcement report a Class II drug recall of Sterile Eye Drops Advanced Relief, made by K.C. Pharmaceuticals, Inc. The entry is dated 14 October 2026 and carries recall number D-0004-2027.

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

The text available for this item consists mainly of the search page for the FDA's enforcement report, so it does not provide further detail. It does not give lot numbers, expiry dates, quantities, the date the recall began, or the specific cause of the sterility concern. Nor does it say whether any adverse events have been reported.

For 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 or other sterile products should note the sterility-assurance classification and check whether similar controls apply to their own supply chains.
  • Distributors and retailers handling this product in the US should consult the full FDA enforcement report entry for D-0004-2027 for lot and scope details, which are not given here.
  • Pharmacovigilance teams may wish to monitor for any complaints or adverse event reports linked to the product, though none are mentioned in the source.

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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