Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% recall
FDA recall D-0409-2026 · initiated Mar 3, 2026
K.C. Pharmaceuticals, Inc recalled Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% in Mar 2026 — an FDA Class II recall (D-0409-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 182,424 bottles
Details
- Product
- Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7
- Recalling company
- K.C. Pharmaceuticals, Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Mar 3, 2026
- FDA report date
- Apr 8, 2026
Frequently asked
- Was Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% recalled?
- K.C. Pharmaceuticals, Inc recalled Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% in Mar 2026 — an FDA Class II recall (D-0409-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% recalled?
- Per the FDA enforcement record, the reason for recall D-0409-2026 was: Lack of Assurance of Sterility
- Is a recalled Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05% are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26;. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0409-2026.