FDA-Drug2026-10-14Class IIPROCESSING DEFECT

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

OTHERNationwide distributionDrugs

What this means

K.C. Pharmaceuticals is recalling multiple brands of sterile eye drops (including Equaline, Good Sense, H.E.B, Quality Choice, and TopCare) because the manufacturer cannot confirm the products were properly sterilized. Eye drops must be sterile to be safe for use in the eyes.

  • Check if you have any of the recalled eye drops (Equaline, Good Sense, H.E.B, Quality Choice, or TopCare sterile eye drops in 0.5 fl. oz. bottles with lot numbers AC25B01 or AC25C01).
  • Stop using the recalled product if you have it.
  • Discard the product or return it to the retailer for a refund.
  • Contact K.C. Pharmaceuticals or your pharmacy with 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
182,016 cartons
Manufactured in
3420 Pomona Blvd, N/A, Pomona, CA, United States
Products
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.

UPC codes

  • 041163251144
  • 041220437467
  • 036800036406

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2027

More K.C. Pharmaceuticals recalls

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