FDA Drug recall D-0008-2027
Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant by K C Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0008-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-11 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | K C Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility
Identifiers
| upc | 093351034114 |
|---|---|
| upc | 041163461512 |
| upc | 348201016155 |
| upc | 678112254156 |
| upc | 311917177410 |
| ndc | 70000-0010-1 |
| ndc | 70000-0010-2 |
| ndc | 79903-012-01 |
| code_info | Lot: a) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b)…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; R |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by K C Pharmaceuticals
- Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles…
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
All K C Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.