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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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
Lack of assurance of sterility means the product may be contaminated. Contact with contaminated solutions can lead to eye infections or other serious eye injuries. The recall notes sterility concerns across multiple lots and store-brand lines.
No injuries or incidents have been reported.
1. Stop using the product. 2. Do not discard packaging; preserve bottle and label for records. 3. Contact KC Pharmaceuticals, Inc. via the recall notice email for guidance on refunds, replacements, or further instructions. If you are a patient, consult your healthcare provider. 4. If you have symptoms such as eye redness, pain, discharge, or vision changes, seek medical advice promptly. 5. Keep documentation of communications and receipts for the recall process.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0416-2026 KC Pharmaceuticals, Inc. recall correspondence via email per notice Hours: Not published in recall notice
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