CLASS II ONGOING Drug recall · Reported 8 Apr 2026 · FDA Enforcement Report

Ultra Lubricating Eye Drops (polyethylene recalled

K.C. Pharmaceuticals is recalling Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, distributed nationwide in the US. The recall was initiated on 3 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26.

NDC70000-0457, 70677-1160, 50804-160, 41250-937, 83324-029

UPC0096295137101, 0010939958297, 0846036008210, 0713733428897, 0708820179288, 0635515999305

Quantity recalled245,184 bottles

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-0412-2026
FDA event ID: 98533
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Leader Ultra Lubricating Eye Drops
Manufacturer: Cardinal Health
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2026
FDA classified: 31 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Drug class: Stomach & Acid Reflux Medication

Timeline

3 Mar 2026	Recall initiated by company
31 Mar 2026	Classified by FDA	+28 days
8 Apr 2026	Published in enforcement report	+8 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

Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9.

Where it was distributed

Nationwide in the US

Nationwide

Stores named: Kroger, Publix, Meijer, Walgreens, CVS

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26.

Where was it sold?

Nationwide in the US

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 26 Sep 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 98533

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

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026	CLASS II	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) recalledGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	Dry Eye Relief Eye Drops, (glycerin recalled by K.C. PharmaceuticalsArtificial Tears	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	Sterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness Relief	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	EYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	K.C. Pharmaceuticals	Sterility	Nationwide
8 Apr 2026	CLASS II	Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals	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	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	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

Other Polyethylene Glycol 400 recalls

All 4

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS II	Sterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye Drops	K.C. Pharmaceuticals	Sterility	Nationwide
14 May 2025Drug	CLASS II	Lubricant Eye Drops Solution recalled by BRS Analytical ServicesLubricant Eye Drops Solution	BRS Analytical Services	Sterility	Nationwide
17 Aug 2022Drug	CLASS II	Systane, Lubricant Eye Drops recalled by Mckesson Medical-SurgicalSystane Lubricant	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide