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

Sterile Eye Drops Original Formula (tetrahydrozoline HCl 05%) recalled

K.C. Pharmaceuticals is recalling Sterile Eye Drops Original Formula (tetrahydrozoline HCl 05%), 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) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; i) RG24E01, Exp.: 05/31/26; j) RG24E01, Exp.: 05/31/26; k) RG24E01, Exp.: 05/31/26; L) RG24E01, Exp.: 05/31/26; m) RG24E01, Exp.: 05/31/26; n) RG24G01, Exp.: 07/31/26; o) RG24G01, Exp.: 07/31/26; p) RG24G02, Exp.: 07/31/26; q)RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; r) RG24G02, Exp.: 07/31/26
NDC50804-141
UPC0180410000156, 311917200736, 311917200767, 366715683243, 072036713025, 041220437474
Quantity recalled378,144 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-0413-2026
FDA event ID
98533
Recalling firm
K.C. Pharmaceuticals, Pomona, CA
Manufacturer
Geiss, Destin & Dunn, Inc.
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 2026Recall initiated by company
31 Mar 2026Classified by FDA+28 days
8 Apr 2026Published 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 ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3

Where it was distributed

Nationwide in the US

Nationwide

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

Questions about this recall

Is Sterile Eye Drops Original Formula (tetrahydrozoline HCl 05%) recalled?

Yes. K.C. Pharmaceuticals recalled Sterile Eye Drops Original Formula (tetrahydrozoline HCl 05%) on 3 Mar 2026. The recall is Class II and its status is Ongoing. Recall number D-0413-2026.

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lot: a) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; i) RG24E01, Exp.: 05/31/26; j) RG24E01, Exp.: 05/31/26; k) RG24E01, Exp.: 05/31/26; L) RG24E01, Exp.: 05/31/26; m) RG24E01, Exp.: 05/31/26; n) RG24G01, Exp.: 07/31/26; o) RG24G01, Exp.: 07/31/26; p) RG24G02, Exp.: 07/31/26; q)RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; r) RG24G02, Exp.: 07/31/26

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from K.C. Pharmaceuticals

All 15
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISterile Eye Drops Soothing Tears recalled by K.C. PharmaceuticalsK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IISterile EYE Drops AC (tetrahydrozoline HCl 05%, zinc sulfate 25%) recalledQuality Choice Eye Drops Irritation ReliefK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIEYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye DropsK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IISterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness ReliefK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIDry Eye Relief Eye Drops, (glycerin 2%, hypromellose recalledArtificial TearsK.C. PharmaceuticalsForeign MaterialNationwide

Other Tetrahydrozoline recalls

All 3
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIOriginal Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original FormulaK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIIEye Drops (Tetrahydrozoline HCl 05%), Over the Counter recalledSunmark Eye Drops Original FormulaK C PharmaceuticalsManufacturing (CGMP) DeviationsNationwide