FDA-Drug2026-10-14Class IIPROCESSING DEFECT

K.C. Pharmaceuticals Advanced Relief eye drops recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

What this means

Multiple brands of sterile eye drops manufactured by K.C. Pharmaceuticals—including Leader, Equaline, GoodSense, H.E.B, Medic's Choice, Foster & Thrive, Colirio Manzanilla A+, Publix, Quality Choice, and TopCare—were recalled because the manufacturer cannot guarantee the products are sterile. The affected bottles are 0.5 FL OZ (15 mL) with specific lot numbers and expiration dates ranging from January 2027 to November 2027.

  • Check if you have an affected bottle by comparing the brand, lot number, and expiration date to the FDA recall notice.
  • Do not use the recalled eye drops.
  • Consult your pharmacist or doctor about safe alternatives or how to safely dispose of the product.
  • Contact the distributor or manufacturer listed on your bottle if you have questions.
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The agency's original wording
Hazard

Lack of Assurance of Sterility

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide
Affected count
208,896 cartons
Manufactured in
3420 Pomona Blvd, N/A, Pomona, CA, United States
Products
Sterile 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.

UPC codes

  • 041163253926
  • 041220437450
  • 184125000180
  • 041415067769
  • 036800036413

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2027

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