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

Sterile Lubricant Dry Eye Relief Eye Drops recalled

K.C. Pharmaceuticals is recalling Sterile Lubricant Dry Eye Relief Eye Drops, 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) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027.

NDC70000-0502, 57896-181, 70677-1157

UPC0096295137064, 0096295137071, 0357896184056, 0010939958266, 867166000004, 093351011566

Quantity recalled1,327,248 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-0006-2027
FDA event ID: 99880
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Leader Dry Eye Relief Eye Drops
Manufacturer: CARDINAL HEALTH 110, LLC. DBA LEADER
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

Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.

Where it was distributed

US Nationwide

Nationwide

Stores named: Kroger, H-E-B

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027.

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

Reported	Class	Recall	Company	Reason	Where
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	Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml	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	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 Glycerin recalls

All 12

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	Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye	K.C. Pharmaceuticals	Sterility	Nationwide
20 May 2026Drug	CLASS II	Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalledOasis Tears Pf	Oasis Medical	Sterility	Nationwide
6 May 2026Drug	CLASS II	Optase Dry Eye Intense Drops (Glycerin 0.2%) recalled by Scope HealthOptase	Scope Health	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide