Severity
Moderate
FDA Drug recall · Reported April 8, 2026
Lack of Assurance of Sterility
K.c. Pharmaceuticals, Inc recalled Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL… — a moderate-severity action.
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL… was recalled by K.c. Pharmaceuticals, Inc in April 8, 2026. Reason: Lack of Assurance of Sterility. Check the official notice for the remedy. Verify recall #D-0409-2026 with the FDA Drug before acting.
The recall
K.c. Pharmaceuticals, Inc issued this moderate-severity FDA Drug recall — Lack of Assurance of Sterility.
Sourced from official FDA Drug enforcement records. Verify recall #D-0409-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0409-2026) was formally reported on April 8, 2026, with the manufacturer initiating the action on March 3, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. K.c. Pharmaceuticals, Inc is listed as the recalling firm, operating out of Pomona, CA. Federal records list the affected scope as 182,424 bottles.
The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: Nationwide in the US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 25,414 food recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
182,424 bottles
Related Recalls
6
0 from same agency
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7
Lack of Assurance of Sterility
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0409-2026 |
| Date reported | April 8, 2026 |
| Date initiated | March 3, 2026 |
| Recalling firm | K.c. Pharmaceuticals, Inc |
| Firm location | Pomona, CA |
| Affected scope | 182,424 bottles |
| Distribution | Nationwide in the US |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
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This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported April 8, 2026.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.