Artificial Tears Sterile Lubricant Eye Drops — Class II drug recall D-0416-2026
Ongoing recall by K.C. Pharmaceuticals, Inc, reported 2026-04-08, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0416-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | K.C. Pharmaceuticals, Inc, Pomona, CA, United States |
| Recall initiated | 2026-03-03 |
| Classified | 2026-03-31 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 589,848 bottles |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00011110386007, 00036800093317, 00041415009769, 00070038470083 |
| NDC | 24385-0006, 24385-0006-05, 50804-0110, 50804-0110-01, 70000-0011, 70000-0011-01, 83324-0189, 83324-0189-14 |
| Expiration dates | 2026-04-30, 2026-05-31, 2026-07-31 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0416-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.