FDA Drug recall D-0003-2027
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles by K C Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0003-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-11 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | K C Pharmaceuticals |
| Distribution | US |
Product
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
Lack of Assurance of Sterility
Identifiers
| upc | 041163251144 |
|---|---|
| upc | 041220437467 |
| upc | 036800036406 |
| ndc | 50804-121-01 |
| ndc | 83324-190-14 |
| code_info | 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…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by K C Pharmaceuticals
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FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - 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…
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles
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FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
All K C Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.