Class IIOngoing

Ultra Lubricating Eye Drops (polyethylene 400 0.4% recall

FDA recall D-0412-2026 · initiated Mar 3, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Apr 8, 2026How we research

K.C. Pharmaceuticals, Inc recalled Ultra Lubricating Eye Drops (polyethylene 400 0.4% in Mar 2026 — an FDA Class II recall (D-0412-2026) 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.

Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26.

Quantity recalled: 245,184 bottles

Details

Product: Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9.
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

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Ultra Lubricating Eye Drops (polyethylene 400 0.4% recalled?: K.C. Pharmaceuticals, Inc recalled Ultra Lubricating Eye Drops (polyethylene 400 0.4% in Mar 2026 — an FDA Class II recall (D-0412-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Ultra Lubricating Eye Drops (polyethylene 400 0.4% recalled?: Per the FDA enforcement record, the reason for recall D-0412-2026 was: Lack of Assurance of Sterility
Is a recalled Ultra Lubricating Eye Drops (polyethylene 400 0.4% 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 Ultra Lubricating Eye Drops (polyethylene 400 0.4% are affected?: Distributed: Nationwide in the US. The recall covers these lots — Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, …. 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-0412-2026.

Source: openFDA Drug Enforcement record D-0412-2026 ↗

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