FDA Recall D-0411-2026

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

Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05

Lot / code: Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01, Exp.: 06/30/26; m)

Quantity: 1,023,096 bottles

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0411-2026
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): ARTIFICIAL TEARS, RITE AID EYE DROPS DRY EYE RELIEF, LEADER DRY EYE RELIEF EYE DROPS, FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS, MEIJER DRY EYE RELIEF, GNP EYE DROPS DRY EYE RELIEF
Generic name(s): GLYCERIN, GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL
Manufacturer(s): Geri-Care Pharmaceuticals, Corp, Rite Aid Corporation, CARDINAL HEALTH 110, LLC. DBA LEADER, Strategic Sourcing Services LLC, Meijer Distribution, Inc., AmerisourceBergen
NDC(s): 57896-181, 11822-1067, 70000-0502, 70677-1158, 41250-718, 46122-605
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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