Quality & complianceOfficial

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

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The US regulator's enforcement report records an ongoing nationwide recall, D-0007-2027, for sterile eye drops from K.C. Pharmaceuticals, Inc., citing a lack of assurance of sterility.

The US Food and Drug Administration has published a Class II drug recall for Sterile Eye Drops made by K.C. Pharmaceuticals, Inc. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0007-2027.

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

The text available for this report did not include product strengths, lot numbers, expiry dates, quantities or the recall's initiation date. Readers needing those details should check the full record in the FDA Enforcement Report database.

By way of context, FDA assigns Class II to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is considered remote.

What it means for your team

  • Quality teams with ophthalmic or other sterile products from this firm in their supply chain should consult the full FDA record for lot and code details.
  • Pharmacovigilance teams may wish to check whether any adverse event reports involving the product, such as eye infections, need review or follow-up.
  • Market-access and supply teams should note that the recall is ongoing and nationwide, so availability of the product may be affected.

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 →