FDA Drug recall D-0007-2027
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL)
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL) by K C Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0007-2027 |
| 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
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47011 3; b) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01157 3; c) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-141-01; d) H.E.B Dry Eye, Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; e) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71302 5; f) Circle K, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed: by Circle K Stores Inc., UPC: 1 94283 65135 8; g) Lil' DrugStore, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, UPC: 3 66715 68324 3; h) QC, Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-340-15; i) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; j) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-158-05; k) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20073 6; l) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38597 0.
Reason
Lack of Assurance of Sterility
Identifiers
| upc | 070038470113 |
|---|---|
| upc | 093351011573 |
| upc | 041220437474 |
| upc | 072036713025 |
| upc | 194283651358 |
| upc | 366715683243 |
| upc | 036800036390 |
| upc | 311917200736 |
| upc | 011110385970 |
| ndc | 50804-141-01 |
| ndc | 83324-340-15 |
| ndc | 79903-158-05 |
| code_info | Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/202…Lot: a) RG24N02, Exp.: 11/30/2026; b) RG25K04, Exp.: 09/30/2027; c) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K03, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; d) RG24N02, Exp.: 11/30/2026; e) RG25K04, Exp.: 09/30/2027; f) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K03, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; g) RG24N02, Exp.: 11/30/2026; RG25D01, Exp.: 04/30/2027; RG25D02, Exp.: 04/30/2027; RG25K02, Exp.: 09/30/2027; RG25K04, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25N02, Exp.: 11/30/2027; h) RG25K05, Exp.: 09/30/2027; i) RG24N02, Exp.: 11/30/2026; RG25K04, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25N02, Exp.: 11/30/2027; RG25N03, Exp.: 11/30/2027; j) RG25E01, Exp.: 05/31/2027; RG25K01, Exp.: 09/30/2027; RG25K02, Exp.: 09/30/2027; RG25K05, Exp.: 09/30/2027; RG25M01, Exp.: 10/31/2027; RG25M02, Exp.: 10/3 |
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 - Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 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
All K C Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2027%22
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