FDA Drug recall D-0009-2027
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl o…
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl o… by K C Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0009-2027 |
| 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 High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.
Reason
Lack of Assurance of Sterility
Identifiers
| upc | 614299056190 |
|---|---|
| upc | 311917201672 |
| ndc | 70000-0457-1 |
| ndc | 70000-0457-2 |
| ndc | 50804-160-01 |
| ndc | 1429905619 |
| code_info | Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/202…Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027. |
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
- Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles
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
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals - Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML)
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-0009-2027%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.