D-0003-2027 Class II Ongoing
FDA drug recall D-0003-2027 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: 182,016 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2026
- Initiation Date
- Sep 11, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182,016 cartons
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
US Nationwide
Code Information
Lot: a) AC25C01, Exp.: 3/31/2027; b) AC25B01, Exp.: 2/28/2027; AC25C01, Exp.: 3/31/2027; c) AC25C01, Exp.: 3/31/2027; d) AC25C01, Exp.: 3/31/2027; e) AC25C01, Exp.: 3/31/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0003-2027
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026