D-0008-2027 Class II Ongoing

Recalled by K.C. Pharmaceuticals, Inc. — Pomona, CA

FDA drug recall D-0008-2027 was initiated by K.C. Pharmaceuticals, Inc. on Sep 11, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing.

Recall Details

Product Type
Drugs
Report Date
Oct 14, 2026
Initiation Date
Sep 11, 2026
Voluntary/Mandated
Voluntary: Firm initiated

Product Description

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 for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide

Code Information

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.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0008-2027
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.