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

Sterile EYE Drops AC (tetrahydrozoline HCl recalled

K.C. Pharmaceuticals is recalling Sterile EYE Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 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) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26;

NDC83324-190, 50804-160, 41250-598

UPC0635515995055, 0846036008210, 0041250829188, 070038470106, 093351011580, 311917179544

Quantity recalled182,424 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-0409-2026
FDA event ID: 98533
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Quality Choice Eye Drops Irritation Relief
Manufacturer: Quality Choice
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 AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7

Where it was distributed

Nationwide in the US

Nationwide

Stores named: H-E-B, Meijer, Walgreens

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26;

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	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	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 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	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	Sterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness Relief	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 Tetrahydrozoline recalls

All 5

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%) recalledGoodsense Eye Drops Original Formula	K.C. Pharmaceuticals	Sterility	Nationwide
19 Jul 2023Drug	CLASS II	Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula	K.C. Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
31 Dec 2014Drug	CLASS III	Eye Drops (Tetrahydrozoline HCl 0.05%), Over the Counter recalledSunmark Eye Drops Original Formula	K C Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
26 Nov 2014Drug	CLASS II	Tetrahydrozoline Hydrochloride recalled by Spectrum Laboratory Products	Spectrum Laboratory Products	Manufacturing (CGMP) Deviations	CA