Dry Eye Relief Lubricant Eye Drops — Class II drug recall D-0898-2023
Ongoing recall by K.C. Pharmaceuticals, Inc, reported 2023-07-19, distributed nationwide. CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
| Recall number | D-0898-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | K.C. Pharmaceuticals, Inc, Pomona, CA, United States |
| Recall initiated | 2023-06-13 |
| Classified | 2023-07-07 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 397,430 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00010939621443, 00036800361003, 00041220437412, 00052569137154, 00095072026560, 00357896184056, 00614299056206, 00681131367011, 00713733296922 |
| NDC | 41250-0718, 41250-0718-01, 49035-0280, 49035-0280-01, 49035-0280-02, 49348-0037, 49348-0037-29, 57896-0181, 57896-0181-05 |
| Expiration dates | 2023-06 |
Product
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
Reason for recall
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0898-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.