Recalls / Class II
Class IID-0416-2026
Product
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
- Brand names
- 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 ingredients
- Polyvinyl Alcohol, Unspecified, Povidone, Polyvinyl Alcohol
- Route
- Ophthalmic
- NDCs
- 70000-0011, 50804-110, 24385-006, 83324-189
- FDA application
- M018
- Affected lot / code info
- Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- K.C. Pharmaceuticals, Inc
- Manufacturer
- Cardinal Health
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3420 Pomona Blvd, Pomona, California 91768-3236
Distribution
- Quantity
- 589,848 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2026-03-03
- FDA classified
- 2026-03-31
- Posted by FDA
- 2026-04-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0416-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.