Leader Artificial Tears Sterile Lubricant Eye Drops sold nationwide are recalled due to lack of assurance of sterility. The recall involves multiple store-brand lines distributed by Cardinal Health and others. Consumers should stop using the product immediately and follow recall guidance from KC Pharmaceuticals via email.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact K.C. Pharmaceuticals, Inc or your healthcare provider for guidance. Notification method: E-Mail
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Artificial Tears Sterile Lubricant Eye Drops are OTC products used to relieve dryness and irritation in the eyes. They are sold under multiple store-brand lines and distributed nationwide.
Lack of sterility can expose users to eye infections or other complications. The issue concerns several lot codes across multiple brand lines.
This recall is not described as part of a broader industry pattern.
Consumers may face eye infection risk. The recall affects nearly 590k bottles, potentially impacting patients and healthcare providers who distribute these products.
Lot codes and expiration dates appear on the bottle label and carton. Official recall details are on the FDA enforcement page linked above.
Refund or replacement processing typically occurs within 4-6 weeks after confirmation of eligibility.
Keep product packaging, purchase receipts, and all recall communications. Document lot numbers and expiration dates for records.
Product: Artificial Tears Sterile Lubricant Eye Drops Size: 0.5 FL OZ (15 mL) bottles NDCs: 70000-0011-1; 50804-110-01; 24385-006-05 UPCs: 0 36800 09331 7; 0 70038 47008 3; 0 11110 38600 7; 0 41415 00976 9 Lot numbers: AT24D01; AT24E01; AT24E02; AT24G01 Expirations: 04/30/26; 05/31/26; 07/31/26 Distributors/Brands: Leader (Cardinal Health, Perrigo Direct, AmerisourceBergen, TopCare, Best Choice, Kroger, Publix, Quality Choice) Quantity recalled: 589,848 bottles Recall date: 2026-03-03 Recall number: D-0416-2026 Status: Active Hazard: Lack of Assurance of Sterility Remedy: Stop using the eye-dh
No injuries or incidents have been reported.
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