Quality & complianceOfficial

FDA lists Class II recall of K.C. Pharmaceuticals Redness Relief eye drops over sterility

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The US regulator's enforcement report records an ongoing nationwide recall of Sterile Eye Drops Redness Relief (glycerin 0.25%) because sterility cannot be assured.

The US Food and Drug Administration has listed a Class II recall of Sterile Eye Drops Redness Relief (glycerin 0.25%), made by K.C. Pharmaceuticals, Inc., in its enforcement report dated 14 October 2026.

The recall carries the number D-0008-2027. The stated reason is lack of assurance of sterility. The report shows the recall as ongoing, and distribution is listed as nationwide across the United States.

Under FDA's system, a Class II classification is generally used where exposure to a product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

The page text available for this item contained only search-tool navigation. It gave no details on lot numbers, quantities, expiry dates or how the sterility concern was identified, so those points are not covered here.

What it means for your team

  • Quality teams with sterile ophthalmic products should note that FDA has again cited lack of assurance of sterility as a recall reason for eye drops.
  • Distributors, pharmacies and retailers in the US should check the full FDA enforcement report entry for D-0008-2027 for affected lots before acting.
  • Pharmacovigilance teams may wish to watch for eye-related adverse event reports on glycerin-based redness relief drops.

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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