Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

LEADER ARTIFICIAL TEARS 15 ML

Recalling Firm / Manufacturer: K.C. Pharmaceuticals, Inc (Pomona, CA, United States)

FDA Recall Number: D-0416-2026

Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.

Product & Identification Information

Brand, active ingredients, NDC codes, and manufacturer details

Brand / Trade Name

LEADER ARTIFICIAL TEARS 15 ML

Generic Name

POLYVINYL ALCOHOL, POVIDONE

Active Substance(s)

Polyvinyl Alcohol, Unspecified, Povidone, Polyvinyl Alcohol

Administration Route

Ophthalmic

National Drug Code (NDC)

70000-0011

Total Quantity Recalled

589,848 bottles

Official Reason for Recall

Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

Lack of Assurance of Sterility

Full Product Description

Packaging specifications and labeling details

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 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14

Enforcement & Regulatory Details

FDA classification, report dates, and initiation authority

Health Hazard Classification

Class II

Current Action Status

Ongoing

FDA Enforcement Report Date

April 08, 2026

Firm Initiation Date

March 03, 2026

FDA Classification Date

Mar 31, 2026

Initiation Type

Voluntary: Firm initiated

Affected Lots & Batch Numbers

Product codes, lot numbers, and expiration dates

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.

Distribution Information

Geographic scope of affected shipments

Nationwide in the US

Safety Guidance & Actions

Standard FDA protocol for patients and healthcare providers

Patient Advisory

Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.

Healthcare Provider Guidance

Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API

Recall Number: D-0416-2026

Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC

View Official FDA Source

LEADER ARTIFICIAL TEARS 15 ML

Official Source Provenance

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