Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% recall
FDA recall D-0416-2026 · initiated Mar 3, 2026
K.C. Pharmaceuticals, Inc recalled Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% in Mar 2026 — an FDA Class II recall (D-0416-2026) 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: 589,848 bottles
Details
- Product
- Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
- 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 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% recalled?
- K.C. Pharmaceuticals, Inc recalled Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% in Mar 2026 — an FDA Class II recall (D-0416-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% recalled?
- Per the FDA enforcement record, the reason for recall D-0416-2026 was: Lack of Assurance of Sterility
- Is a recalled Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% 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 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5% are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, E…. 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-0416-2026.