K.C. Pharmaceuticals Eye Drops
Artificial Tears Sterile Lubricant Eye Drops lack assurance of sterility.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
K.C. Pharmaceuticals, Inc. recalled multiple sterile eye drop products due to lack of assurance of sterility, beginning September 11, 2026, and added to the FDA's Enforcement Report on October 5, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
8 products
Affected if its lot code and NDC or UPC are listed under that product.
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes)…
- NDC / UPC
- NDC 70000-0457-1
- UPC 6 1429905619 0
- NDC 50804-160-01
- UPC 3 11917 20167 2
- Lot
- SU25B01
- SU25N01
- SU25N02
Eye Drops Maximum, Redness Relief, Sterile, 1/2 fl oz (0.5 ML); a) exchange select
- NDC / UPC
- UPC 6 14299 89636 9
- UPC 0 72036 73589 8
- UPC 7 84847 57549 4
- NDC 11673-100-01
- UPC 0 36800 21123 0
- UPC 3 11917 20075 0
- Lot
- CM25E02
- CM25M01
- CM25C01
- CM25C02
- CM25C03
- CM25F01
- CM25A02
- CM25B01
- CM25E01
- CM25K01
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles; a)…
- NDC / UPC
- UPC 0 70038 47008 3
- NDC 70000-0011-1
- NDC 24385-006-05
- NDC 50804-110-01
- NDC 55651-008-01
- UPC 0 41415 00976 9
- NDC 83324-189-14
- UPC 0 36800 09331 7
- UPC 3 11917 06503 8
- UPC 0 11110 38600 7
- Lot
- AT25B01
- AT24N01
- AT25D01
- AT25F01
- AT25F02
- AT25K02
- AT25K01
Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves…
- NDC / UPC
- NDC 70000-0010-1
- UPC 0 93351 03411 4
- UPC 0 41163 46151 2
- UPC 3 48201 01615 5
- UPC 6 78112 25415 6
- NDC 79903-012-01
- UPC 3 11917 17741 0
- UPC 130209
- Lot
- RL25D01
- RL25G01
- RL25K05
- RL25N03
- RL25E01
- RL25G02
- RL25G03
- RL25G04
- RL25H02
- RL25H03
- RL25H04
- RL25K01
- RL25K02
- RL25K03
- RL25K04
- RL25M01
- RL25M02
- RL25M03
- RL25M04
- RL25N01
- RL25N02
- RL25N04
- RL25H01
- RL25M05
Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline
- NDC / UPC
- UPC 0 41163 25114 4
- NDC 50804-121-01
- UPC 0 41220 43746 7
- NDC 83324-190-14
- UPC 0 36800 03640 6
- Lot
- AC25C01
- AC25B01
Sterile Eye Drops Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5…
- NDC / UPC
- NDC 70000-0456-1
- UPC 0 41163 25392 6
- NDC 50804-130-01
- UPC 0 41220 43745 0
- NDC 55651-025-01
- NDC 70677-1158-1
- UPC 1 84125 00018 0
- UPC 0 41415 06776 9
- NDC 83324-191-14
- UPC 0 36800 03641 3
- Lot
- AR25A02
- AR25A01
- AR25N01
- AR25F01
Sterile Eye Drops, Original, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz…
- NDC / UPC
- UPC 0 70038 47011 3
- UPC 0 93351 01157 3
- NDC 50804-141-01
- UPC 0 41220 43747 4
- UPC 0 72036 71302 5
- UPC 1 94283 65135 8
- UPC 3 66715 68324 3
- NDC 83324-340-15
- UPC 0 36800 03639 0
- NDC 79903-158-05
- UPC 3 11917 20073 6
- UPC 0 11110 38597 0
- Lot
- RG24N02
- RG25K04
- RG25D01
- RG25D02
- RG25K02
- RG25K03
- RG25N02
- RG25N03
- RG25K05
- RG25M01
- RG25E01
- RG25K01
- RG25M02
- RG25P01
Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 fl oz (15 mL); a) Leader
- NDC / UPC
- NDC 70000-0502-1
- UPC 8 67166 00000 4
- UPC 0 93351 01156 6
- UPC 6 14299 05620 6
- NDC 57896-181-05
- UPC 0 41220 43741 2
- UPC 0 72036 71303 2
- NDC 70677-1157-1
- UPC 0 36800 36100 3
- Lot
- LT25B01
- LT25D02
- LT25K01
- LT25M02
- LT25D01
- LT25M01
- LT25N01
- LT25N02
Details
- Company began the recall
- Event ID
- 99880
- Company
- K.C. Pharmaceuticals, Inc.
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
