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
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
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 13 Jun 2023 | Recall initiated by company | |
| 7 Jul 2023 | Classified by FDA | +24 days |
| 19 Jul 2023 | Published 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
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Original Eye Drops recalled by K.C. PharmaceuticalsSunmark Eye Drops Original Formula | K.C. Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from K.C. Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile High Performance Ultra Lubricating Eye Drops recalledLeader Ultra Lubricating Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
Other Glycerin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalledOasis Tears Pf | Oasis Medical | Sterility | Nationwide |
| Drug | CLASS II | Optase Dry Eye Intense Drops (Glycerin 0.2%) recalled by Scope HealthOptase | Scope Health | Sterility | Nationwide |