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

Sterile Eye Drops Redness Lubricant (glycerin recalled

K.C. Pharmaceuticals is recalling Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 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) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k)

NDC70000-0010, 70677-1161

UPC0096295137620, 0096295137637, 0010939958310, 348201016155, 348201016131, 041163461512

Quantity recalled315,144 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-0414-2026
FDA event ID: 98533
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Leader Eye Drops Redness Relief
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: Eye Drops

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

Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4

Where it was distributed

Nationwide in the US

Nationwide

Stores named: Walgreens, Rite Aid

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k)

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	Ultra Lubricating Eye Drops (polyethylene recalledLeader Ultra Lubricating Eye Drops	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	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 15

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

Other Glycerin recalls

All 9

Reported	Class	Recall	Company	Reason	Where
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
8 Apr 2026Drug	CLASS II	Dry Eye Relief Eye Drops, (glycerin recalled by K.C. PharmaceuticalsArtificial Tears	K.C. Pharmaceuticals	Sterility	Nationwide
19 Jul 2023Drug	CLASS II	Dry Eye Relief Lubricant Eye Drops, (Glycerin recalledEquate Eye Drops Dry Eye Relief	K.C. Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide