Recall: 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
This page indexes a United States Food and Drug Administration (FDA) enforcement report describing a drug recall associated with K.c. Pharmaceuticals, Inc. The recalled item is described in the source record as 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. The FDA assigned this recall a regulatory classification of Class II, and the recall is currently recorded with a status of Ongoing. The recall is identified in FDA systems by recall number D-0416-2026. The recalling firm is associated with CA, United States in the source record. This recall record was published on 2026-04-08. Every field on this page is reproduced as a regulatory data point from the official openFDA dataset and is intended to help you locate and verify the original report. It is not a safety instruction, a clinical assessment, or advice about whether to use any product. Confirm all details against the linked FDA source before relying on them.
FDA recall data
| Recall number | D-0416-2026 |
|---|---|
| Event ID | 98533 |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Product description | 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 |
| Recalling firm | K.c. Pharmaceuticals, Inc |
| Distribution pattern | Nationwide in the US |
| State | CA |
| Country | United States |
| Report date | 2026-04-08 |
| Recall initiation date | 2026-03-03 |
Reason for recall (source data field)
The following text is the recalling firm's stated reason, reproduced verbatim from the FDA enforcement report as a regulatory data field. It is presented for identification and verification only — it is not a safety instruction, a clinical assessment, or advice.
Lack of Assurance of Sterility
How to interpret this recall record
A recall record means a firm has removed or corrected a marketed product in cooperation with the FDA, and that the agency has logged the action in its enforcement reports. The classification (Class II) is the FDA's regulatory severity tier for the action; it describes the agency's assessment of the recall event in administrative terms, not a personalised risk statement for any individual. The status (Ongoing) reflects where the recall sits in its lifecycle. Read this entry as a pointer to an official report: open the linked FDA source to confirm the product, lot scope, dates, and current status before acting on any of it.
What this record does not mean
This recall record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.
Related manufacturer
This recall is attributed to K.c. Pharmaceuticals, Inc. That page aggregates the firm's other indexed recall and shortage records as coverage-limited regulatory signals (not quality ratings).
Related recalls (Class II)
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- fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. · 2026-05-27
- Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). · 2026-05-27
- Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. · 2026-05-27
- Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). · 2026-05-27
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0416-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-04-08
- Ingested
- 2026-06-09
- Record hash
b776601d38cd818f
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.