Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | LEADER ULTRA LUBRICATING EYE DROPS, FOSTER AND THRIVE LUBRICATING TEARS LUBRICANT EYE DROPS, GOODSENSE ULTRA LUBRICANT EYE DROPS, MEIJER ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE, QUALITY CHOICE LUBRICANT EYE DROPS HIGH PERFORMANCE |
| Generic name | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL |
| Active ingredient(s) | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL |
| Distributed by / for | CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com |
| NDC | 70000-0457-1 |
| Full product label | Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9. |
| Recalling firm | K.C. Pharmaceuticals, Inc |
| Distribution | Nationwide in the US |
| Quantity | 245,184 bottles |
| Recall initiated | 2026-03-03 |
| Report date | 2026-04-08 |
| Recall completed | — |
| Recall number | D-0412-2026 |
| 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 ↗