FDA Drug recall D-0002-2027
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 2026-10-14
On 2026-10-14 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-0002-2027 |
| 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
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.
Reason
Lack of Assurance of Sterility
Identifiers
| upc | 070038470083 |
|---|---|
| upc | 041415009769 |
| upc | 036800093317 |
| upc | 311917065038 |
| upc | 011110386007 |
| ndc | 70000-0011-1 |
| ndc | 24385-006-05 |
| ndc | 50804-110-01 |
| ndc | 55651-008-01 |
| ndc | 83324-189-14 |
| code_info | Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25…Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026. |
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 - Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML)
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-0002-2027%22
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