Recall of Artificial Tears Eye Drops Due to Sterility Concerns

Source: FDA · United States

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K.C. Pharmaceuticals, Inc. is voluntarily recalling over 589,848 bottles of artificial tears eye drops 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.

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What Happened

K.C. Pharmaceuticals, Inc. is recalling certain artificial tears eye drops 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: a) LEADER ARTIFICIAL TEARS 15 ML, NDC 70000-0011-1; b) GOOD SENSE ARTIFICIAL TEARS, NDC 50804-110-01; c) GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS, NDC 24385-006-05; d) QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS, NDC 83324-189-14; and others such as TopCare health, Best Choice, Kroger, P, with UPC codes including 0096295137644, 0180410000163, 0087701104060, 0635515992238, 036800093317, 070038470083, 011110386007, and 041415009769. The recall involves 589,848 bottles with lot numbers such as AT24D01 (exp. 04/30/26), AT24E01 (exp. 05/31/26), AT24E02 (exp. 05/31/26), and AT24G01 (exp. 07/31/26). These products were distributed nationwide in the US.

What You Should Do

Consumers who have the affected products should stop using them immediately and contact the recalling firm, K.C. Pharmaceuticals, Inc., at their address 3420 Pomona Blvd, Pomona, CA 91768-3236, for instructions on returns or refunds, as the recall was initiated via e-mail notification.

Why This Matters

This recall highlights potential risks associated with non-sterile eye drops, which could affect a large number of consumers nationwide and underscores the importance of product safety in pharmaceuticals.

Source

This recall is attributed to the FDA under recall number D-0416-2026. For more information, visit the FDA website at https://www.fda.gov.

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 voluntarily recalling over 589,848 bottles of artificial tears eye drops 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.