Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | LEADER ARTIFICIAL TEARS 15 ML, GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS, GOOD SENSE ARTIFICIAL TEARS, ARTIFICIAL TEARS, QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS |
| Generic name | POLYVINYL ALCOHOL, POVIDONE |
| Active ingredient(s) | POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, POVIDONE, UNSPECIFIED, POLYVINYL ALCOHOL |
| Distributed by / for | VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com |
| NDC | 70000-0011-1 |
| Full product label | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7. |
| Recalling firm | K.C. Pharmaceuticals, Inc. |
| Distribution | US Nationwide |
| Quantity | 505,896 cartons |
| Recall initiated | 2026-09-11 |
| Report date | 2026-10-14 |
| Recall completed | — |
| Recall number | D-0002-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pomona CA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗