FDA Recall D-0410-2026
K.C. Pharmaceuticals, Inc · Pomona, CA
Class II Ongoing 72 days on record
Product
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0410-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- 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)
- QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS, FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS, GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER, CODE RED EYE DROPS REDNESS RELIEF
- Generic name(s)
- DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL
- Manufacturer(s)
- Chain Drug Marketing Association, Inc., Strategic Sourcing Services LLC, Geiss, Derstin & Dunn, Inc., 4 Trees, LLC
- NDC(s)
83324-191, 70677-1158, 50804-130, 83817-963- 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.