FDA Recall of Various Eye Drop Brands Over Sterility Concerns

Source: FDA · United States

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K.C. Pharmaceuticals, Inc. is recalling 303,216 bottles of multiple eye drop products distributed nationwide due to a lack of assurance of sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Eye Drops) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

K.C. Pharmaceuticals, Inc. is recalling certain eye drop products because of a lack of assurance of sterility, as classified by the FDA as a Class II recall.

Which Products Are Affected

The affected products include various eye drops such as: a) Walgreens Advanced Relief Eye Drops, UPC 3 11917 20074 3; b) Kroger Advanced Relief Eye Drops; c) CVS Health Advanced Relief Eye Drops, UPC 0 50428 43544 1; d) QC-Quality Choice Moisturizing Relief Eye Drops, NDC 83324-191-14; e) Discount Drug Mart Eye Drops, UPC 0 93351 01155 9; f) Foster & Thrive Advanced Relief Eye Drops, NDC 70677-1158-1; g) GoodSense Eye Drops Advanced Relief Moisturizer, NDC 50804-130-01; h) TopCare Health Eye Drops, UPC 0 36800 03641 3; i) DG Health Sterile Eye Drops, UPC 0 95072 02556 3; and j) Code Red Eye Drops Redness Relief, NDC 83817-963-01. A total of 303,216 bottles are affected, with specific lots including AR24D01 (exp. 04/30/26), AR24G01 (exp. 07/31/26), AR24G02 (exp. 07/31/26), and AR24M01 (exp. 10/31/26). These products were distributed nationwide in the US.

What You Should Do

Consumers who have the affected eye drops should immediately stop using them and contact the recalling firm, K.C. Pharmaceuticals, Inc., for instructions on returns or refunds. The initial notification was made via e-mail.

Why This Matters

This recall is significant because unsterile eye drops could potentially lead to eye infections, posing a risk to consumer health. It affects a large number of products distributed across the United States, highlighting the importance of sterility in ophthalmic drugs.

Source

FDA recall notice for recall number D-0410-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
K.C. Pharmaceuticals, Inc. is recalling 303,216 bottles of multiple eye drop products distributed nationwide due to a lack of assurance of sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.