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Home Drug Recalls D-0008-2027
Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

LEADER EYE DROPS REDNESS RELIEF

Recalling Firm / Manufacturer: K.C. Pharmaceuticals, Inc. (Pomona, CA, United States)
FDA Recall Number: D-0008-2027
View FDA Source
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 EYE DROPS REDNESS RELIEF
Generic Name
GLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Active Substance(s)
Glycerin, Naphazoline Hydrochloride
Administration Route
Ophthalmic
National Drug Code (NDC)
70000-0010
Total Quantity Recalled
N/A
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

Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 14, 2026
Firm Initiation Date
September 11, 2026
FDA Classification Date
Oct 05, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot: a) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; c) RL25D01, Exp.: 04/30/2027; d) RL25E01, Exp.: 05/31/2027; RL25K05, Exp.: 09/30/2027; e) RL25G02, Exp.: 07/31/2027; RL25G03, Exp.: 07/31/2027; RL25G04, Exp.: 07/31/2027; RL25H02, Exp.: 08/30/2028; RL25H03, Exp.: 08/30/2028; RL25H04, Exp.: 08/30/2028; RL25K01, Exp.: 09/30/2027; RL25K02, Exp.: 09/30/2027; RL25K03, Exp.: 09/30/2027; RL25K04, Exp.: 09/30/2027; RL25M01, Exp.: 10/31/2027; RL25M02, Exp.: 10/31/2027; RL25M03, Exp.: 10/31/2027; RL25M04, Exp.: 10/31/2027; RL25N01, Exp.: 11/30/2027; RL25N02, Exp.: 11/30/2027; RL25N04, Exp.: 11/30/2027; f) RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027; g) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; h) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027.
Distribution Information
Geographic scope of affected shipments

US Nationwide

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-0008-2027
Questo Retrieval Date: October 21, 2026 00:00 1792540811UTCC
View Official FDA Source

System Notice

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