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

Sterile EYE Drops Advanced Relief, (dextran recalled

K.C. Pharmaceuticals is recalling Sterile EYE Drops Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and, 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) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.

NDC70000-0456, 50804-130, 55651-025, 70677-1158, 83324-191

UPC0096295136470, 0180410000194, 0095072012518, 0010939958273, 0635515903760, 041163253926

Quantity recalled208,896 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-0004-2027
FDA event ID: 99880
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Leader Advanced Relief Eye Drops
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: Stomach & Acid Reflux Medication

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 EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.

Where it was distributed

US Nationwide

Nationwide

Stores named: Publix, H-E-B

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.

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

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, 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 Dextran 70 recalls

All 2

Reported	Class	Recall	Company	Reason	Where
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