Home / Recalls / K.C. Pharmaceuticals, Inc. / D-0004-2027

D-0004-2027 Class II Ongoing

Recalled by K.C. Pharmaceuticals, Inc. — Pomona, CA

FDA drug recall D-0004-2027 was initiated by K.C. Pharmaceuticals, Inc. on Sep 11, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 208,896 cartons.

Recall Details

Product Type
Drugs
Report Date
Oct 14, 2026
Initiation Date
Sep 11, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
208,896 cartons

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide

Code Information

Lot: 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.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0004-2027
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by K.C. Pharmaceuticals, Inc.

  • D-0005-2027 Class II — Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange… (Sep 11, 2026)
  • D-0007-2027 Class II — Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿… (Sep 11, 2026)
  • D-0006-2027 Class II — Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER… (Sep 11, 2026)
  • D-0002-2027 Class II — Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone… (Sep 11, 2026)
  • D-0009-2027 Class II — Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400… (Sep 11, 2026)
  • D-0008-2027 Class II — Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02%… (Sep 11, 2026)
  • D-0003-2027 Class II — Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl… (Sep 11, 2026)
  • D-0412-2026 Class II — Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%)… (Mar 3, 2026)
  • D-0415-2026 Class II — STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene… (Mar 3, 2026)
  • D-0413-2026 Class II — Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ… (Mar 3, 2026)

FDA data resources