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
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
- 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 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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Soothing Tears recalled by K.C. Pharmaceuticals | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl 05%, zinc sulfate 25%) recalledQuality Choice Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | EYE Drops Advanced Relief, (dextran recalled by K.C. PharmaceuticalsQuality Choice Moisturizing Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Eye Drops Redness Lubricant (glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Dry Eye Relief Eye Drops, (glycerin 2%, hypromellose recalledArtificial Tears | K.C. Pharmaceuticals | Foreign Material | Nationwide |
Other Tetrahydrozoline recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Eye Drops (Tetrahydrozoline HCl 05%), Over the Counter recalledSunmark Eye Drops Original Formula | K C Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |