RecallHawk
Class II Recall

Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Excha

K.C. Pharmaceuticals, Inc.

Summary

The FDA issued a Class II for Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange sele by K.C. Pharmaceuticals, Inc.. Reason: Lack of Assurance of Sterility.

Details

Source

Drug Recall

External ID

D-0005-2027

Action Date

2026-10-14

Status

Ongoing

Category

drug

Product Description

Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 89636 9; b) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 73589 8; c) TYSON, MIKE RED EYE DROPS, Distributed by: JBRANDS Distribution, Miami, FL 33009, UPC: 7 84847 57549 4; d) up & up, Distributed by: Target Corporation, Minneapolis, MN 55403, NDC 11673-100-01; e) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 21123 0; f) Walgreens, DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20075 0.

Lot/Code Info: Lot: a) CM25E02, Exp.: 5/31/2027; CM25M01, Exp.: 10/31/2027; b) CM25E02, Exp.: 5/31/2027; c) CM25C01, Exp.: 3/31/2027; CM25C02, Exp.: 3/31/2027; CM25C03, Exp.: 3/31/2027; CM25E02, Exp.: 5/31/2027; CM25F01, Exp.: 6/30/2027; CM25A02, Exp.: 1/1/2027; CM25B01, Exp.: 2/28/2027; d) CM25B01, Exp.: 2/28/2027; CM25E01, Exp.: 5/31/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; e) CM25B01, Exp.: 2/28/2027; CM25F01, Exp.: 6/30/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027; f) CM25B01, Exp.: 2/28/2027; CM25E02, Exp.: 5/31/2027; CM25K01, Exp.: 9/30/2027; CM25M01, Exp.: 10/31/2027.

Quantity Affected: 1,435,830 cartons

Reason for Recall

Lack of Assurance of Sterility

Distribution

US Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-11

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-0005-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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