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

Dry Eye Relief Lubricant Eye Drops, (Glycerin recalled

K.C. Pharmaceuticals is recalling Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene, 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) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023
NDC49035-280, 49348-037, 41250-718, 57896-181
UPC0681131349864, 0010939167330, 0713733296922, 0357896184056, 681131367011, 095072026560
Quantity recalled397,430 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-0898-2023
FDA event ID
92533
Recalling firm
K.C. Pharmaceuticals, Pomona, CA
Manufacturer
Wal-Mart Stores, Inc.
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

Timeline

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

Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05

Where it was distributed

Nationwide in the USA

Nationwide

Stores named: Walmart, Meijer

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) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023

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
ReportedClassRecallCompanyReasonWhere
CLASS IIOriginal Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original FormulaK.C. PharmaceuticalsManufacturing (CGMP) DeviationsNationwide

More recalls from K.C. Pharmaceuticals

All 23
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness ReliefK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IISterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation ReliefK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIArtificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 MlK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIEye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief EyeK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IISterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye DropsK.C. PharmaceuticalsSterilityNationwide

Other Glycerin recalls

All 11
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness ReliefK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIEye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief EyeK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IISterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye DropsK.C. PharmaceuticalsSterilityNationwide
DrugCLASS IIOasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalledOasis Tears PfOasis MedicalSterilityNationwide
DrugCLASS IIOptase Dry Eye Intense Drops (Glycerin 0.2%) recalled by Scope HealthOptaseScope HealthSterilityNationwide