Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl o
Summary
The FDA issued a Class II for Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fas by K.C. Pharmaceuticals, Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0007-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-141-01; d) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; e) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71302 5; f) Circle K, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed: by Circle K Stores Inc., UPC: 1 94283 65135 8; g) Lil' DrugStore, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, UPC: 3 66715 68324 3; h) QC, Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-340-15; i) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; j) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-158-05; k) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20073 6; l) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38597 0.
Lot/Code Info: Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K03, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; d) RG24N02, Exp.: 11/30/2026; e) RG25K04, Exp.: 09/30/2027; f) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; g) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; h) RG25K05, Exp.: 09/30/2027; i) RG24N02, Exp.: 11/30/2026; RG25K04, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; j) RG25E01, Exp.: 05/31/2027; RG25K01, Exp.: 09/30/2027; RG25K02, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25M02, Exp.: 10/31/2027; RG25P01, Exp.: 12/31/2027; k) RG25D01, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; l) RG24N02, Exp.: 11/30/2026;
Quantity Affected: 1,025,448 cartons
Reason for Recall
Lack of Assurance of Sterility
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-11
Company
Pomona, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
K.C. Pharmaceuticals, Inc. has 18 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (K.C. Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does K.C. Pharmaceuticals, Inc. have FDA actions?
K.C. Pharmaceuticals, Inc. has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0007-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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