FDA Recall D-0416-2026

K.C. Pharmaceuticals, Inc · Pomona, CA

Class II Ongoing 72 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: 589,848 bottles

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0416-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the US
Recall initiated: 2026-03-03
Classified by FDA Center: 2026-03-31
FDA published: 2026-04-08
Recalling firm: K.C. Pharmaceuticals, Inc
Firm location: Pomona, CA

Drug identification

Brand name(s): 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(s): POLYVINYL ALCOHOL, POVIDONE
Manufacturer(s): Cardinal Health, Geiss, Destin & Dunn, Inc., AmerisourceBergen, Chain Drug Marketing Association, Inc.
NDC(s): 70000-0011, 50804-110, 24385-006, 83324-189
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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