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Class II · ModerateActive recall

Leader Advanced Relief Eye Drops

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027.
Where it was soldUS Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byKC Pharmaceuticals, Inc., Pomona, CA 91768
Brand nameLEADER ADVANCED RELIEF EYE DROPS, GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER, MEDICS CHOICE EYE DROPS ADVANCED, FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS, QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
Generic nameDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL, TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL
Active ingredient(s)DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
Distributed by / forCARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com
NDC70000-0456-1
Show the full FDA record
Full product labelSterile 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) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.
Recalling firmK.C. Pharmaceuticals, Inc.
DistributionUS Nationwide
Quantity208,896 cartons
Recall initiated2026-09-11
Report date2026-10-14
Recall completed—
Recall numberD-0004-2027
ClassificationClass II
FDA statusOngoing
Origin on filePomona CA United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.