FDA Drug recall D-0416-2026
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles
- FDA Drug
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 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-0416-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-03 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | K C Pharmaceuticals |
| Distribution | US |
Product
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
Reason
Lack of Assurance of Sterility
Identifiers
| upc | 036800093317 |
|---|---|
| upc | 070038470083 |
| upc | 011110386007 |
| upc | 041415009769 |
| ndc | 70000-0011-1 |
| ndc | 50804-110-01 |
| ndc | 24385-006-05 |
| ndc | 83324-189-14 |
| code_info | Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01,…Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0416-2026%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.