Why it was recalled
Lack of Assurance of Sterility
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0416-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 3, 2026
- FDA report date
- Apr 8, 2026
- Quantity
- 589,848 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- K.C. Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-0416-2026, exactly as published.
Show all FDA fields
- City
- Pomona
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98533
- Address
- 3420 Pomona Blvd
- Code information
- 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.
- Postal code
- 91768-3236
- Report date
- Apr 8, 2026
- Product type
- Drugs
- Recall number
- D-0416-2026
- Classification
- Class II
- Recalling firm
- K.C. Pharmaceuticals, Inc
- Product quantity
- 589,848 bottles
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Mar 3, 2026
- Initial firm notification
- Center classification date
- Mar 31, 2026