Artificial Tears Sterile Lubricant Eye Drops Recall - 589,848 Bottles, Lack of Sterility Assurance
Summary
FDA classified a Class II recall for K.C. Pharmaceuticals' Artificial Tears Sterile Lubricant Eye Drops (Leader brand) distributed nationwide. The recall affects 589,848 bottles due to lack of assurance of sterility. Affected lot numbers include AT24D01, AT24E01, AT24E02, and AT24G01 with expiration dates through July 2026. Healthcare providers and patients should verify product stock against the recalled lot codes.
What changed
FDA classified a Class II voluntary recall initiated by K.C. Pharmaceuticals for Artificial Tears Sterile Lubricant Eye Drops. The 589,848 affected bottles (Leader brand, distributed by Cardinal Health) are being recalled due to lack of sterility assurance. The recall covers multiple lot numbers across product lines with expiration dates from April to July 2026.
Healthcare providers, pharmacies, and distributors should verify their inventory against the recalled lot codes (AT24D01, AT24E01, AT24E02, AT24G01) and follow established recall procedures. While the recall is voluntary, FDA's Class II classification indicates the sterility concern may cause temporary or reversible health consequences if contaminated product is used.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
K.C. Pharmaceuticals, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0416-2026 · 20260408 · Ongoing · Voluntary: Firm initiated
Product
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26.
Quantity
589,848 bottles
Firm Notification Method
Distribution
Nationwide in the US
Initiated
20260303
FDA Classified
20260331
Product Registration
Brand: LEADER ARTIFICIAL TEARS 15 ML
Generic: POLYVINYL ALCOHOL, POVIDONE
Manufacturer: Cardinal Health
Application: M018
NDC: 70000-0011, 50804-110, 24385-006
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
Uses for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Dosage & Administration
Directions instill 1 or 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor
Warnings
Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lens before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. if a...
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