CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report

Artificial Tears Sterile Lubricant Eye Drops recalled

K.C. Pharmaceuticals is recalling Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), distributed nationwide in the US. The recall was initiated on 11 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026.

NDC70000-0011, 24385-006, 50804-110, 55651-008, 83324-189

UPC0096295137644, 0087701104060, 0180410000163, 0095072015519, 0635515992238, 070038470083

Quantity recalled505,896 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0002-2027
FDA event ID: 99880
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Leader Artificial Tears 15 Ml
Manufacturer: Cardinal Health
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2026
FDA classified: 5 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Eye Drops

Timeline

11 Sep 2026	Recall initiated by company
5 Oct 2026	Classified by FDA	+24 days
14 Oct 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.

Where it was distributed

US Nationwide

Nationwide

Stores named: Kroger, Publix, Walgreens

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026.

Where was it sold?

US Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 99880

This product is part of a recall event; the main page for the event is Sterile Lubricant Dry Eye Relief Eye Drops recalled.

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026	CLASS II	Sterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Sterile EYE Drops Advanced Relief, (dextran recalledLeader Advanced Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Sterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026	CLASS II	Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide

More recalls from K.C. Pharmaceuticals

All 23

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 Oct 2026Drug	CLASS II	Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide

Other Polyvinyl Alcohol recalls

All 6

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
14 May 2025Drug	CLASS II	Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol	BRS Analytical Services	Sterility	Nationwide
8 Jan 2025Drug	CLASS III	Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Kilitch Healthcare India	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief	Cardinal Health	Sterility	Nationwide