CLASS II ONGOING Drug recall · Reported 19 Jul 2023 · FDA Enforcement Report

Original Eye Drops recalled by K.C. Pharmaceuticals

K.C. Pharmaceuticals is recalling Original Eye Drops, distributed nationwide in the US. The recall was initiated on 13 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023

NDC49348-037, 50804-141, 41250-814

UPC0010939167330, 0180410000156, 0041250829164, 095072005565, 041415010765, 010939167330

Quantity recalled341,568 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-0897-2023
FDA event ID: 92533
Recalling firm: K.C. Pharmaceuticals, Pomona, CA
Brand: Sunmark Eye Drops Original Formula
Manufacturer: Strategic Sourcing Services LLC
Classification: Class II
Status: Ongoing
Recall initiated: 13 Jun 2023
FDA classified: 7 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Manufacturing (CGMP) Deviations
Drug class: Eye Drops

Timeline

13 Jun 2023	Recall initiated by company
7 Jul 2023	Classified by FDA	+24 days
19 Jul 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Product as listed by the FDA

Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3

Where it was distributed

Nationwide in the USA

Nationwide

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

Questions about this recall

Why was it recalled?

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Which lots are affected?

Lot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023

Where was it sold?

Nationwide in the USA

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

1 other product · FDA event 92533

This product is part of a recall event; the main page for the event is Dry Eye Relief Lubricant Eye Drops, (Glycerin recalled.

Reported	Class	Recall	Company	Reason	Where
19 Jul 2023	CLASS II	Dry Eye Relief Lubricant Eye Drops, (Glycerin recalledEquate Eye Drops Dry Eye Relief	K.C. Pharmaceuticals	Manufacturing (CGMP) Deviations	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	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	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

Other Tetrahydrozoline recalls

All 5

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Drug	CLASS II	Sterile EYE Drops AC (tetrahydrozoline HCl recalledQuality Choice Eye Drops Irritation Relief	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
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