Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | LEADER ARTIFICIAL TEARS 15 ML, GOOD SENSE ARTIFICIAL TEARS, GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS, QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS |
| Generic name | POLYVINYL ALCOHOL, POVIDONE |
| Active ingredient(s) | POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, POLYVINYL ALCOHOL |
| Distributed by / for | 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) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 |
| Recalling firm | K.C. Pharmaceuticals, Inc |
| Distribution | Nationwide in the US |
| Quantity | 589,848 bottles |
| Recall initiated | 2026-03-03 |
| Report date | 2026-04-08 |
| Recall completed | — |
| Recall number | D-0416-2026 |
| 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 ↗