Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | LEADER EYE DROPS REDNESS RELIEF, EQUATE REDNESS AND DRY EYE RELIEF EYE DROPS |
| Generic name | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE, GLYCERIN, NAPHAZOLINE HCL |
| Active ingredient(s) | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE |
| Distributed by / for | CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com |
| NDC | 70000-0010-1 |
| Full product label | 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. |
| Recalling firm | K.C. Pharmaceuticals, Inc. |
| Distribution | US Nationwide |
| Quantity | N/A |
| Recall initiated | 2026-09-11 |
| Report date | 2026-10-14 |
| Recall completed | — |
| Recall number | D-0008-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pomona CA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗