FDA-Drug2026-10-14Class IIPROCESSING DEFECT

K.C. Pharmaceuticals sterile eye drops recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

What this means

K.C. Pharmaceuticals has recalled multiple brands of sterile redness relief eye drops (Leader, Discount Drug Mart, Equaline, Colirio Ojo de Aguila, Clear Eyes, Equate, Walgreens, and Xpect) due to lack of assured sterility. The affected drops were distributed nationwide across multiple retailers.

  • Check if you have any of the recalled eye drops by brand and lot number listed on the FDA website.
  • Stop using the product if you have an affected lot.
  • Return the product to where you purchased it or dispose of it safely.
  • Contact your eye doctor or pharmacist if you have questions about your eye health.
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The agency's original wording
Hazard

Lack of Assurance of Sterility

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide
Affected count
N/A
Manufactured in
3420 Pomona Blvd, N/A, Pomona, CA, United States
Products
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.

UPC codes

  • 093351034114
  • 041163461512
  • 348201016155
  • 678112254156
  • 311917177410

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2027

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