FDA Announces Recall of Ultra Lubricating Eye Drops

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

The FDA is overseeing a voluntary recall of various brands of ultra lubricating eye drops due to lack of assurance of sterility, affecting 245,184 bottles distributed nationwide in the US.

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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Recall Article

What Happened

K.C. Pharmaceuticals, Inc. is recalling certain lots of ultra lubricating eye drops because of a lack of assurance of sterility.

Which Products Are Affected

The affected products include: LEADER ULTRA LUBRICATING EYE DROPS, FOSTER AND THRIVE LUBRICATING TEARS LUBRICANT EYE DROPS, GOODSENSE ULTRA LUBRICANT EYE DROPS, MEIJER ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE, QUALITY CHOICE LUBRICANT EYE DROPS HIGH PERFORMANCE, and others such as Harris Teeter, Walgreens, Publix, Kroger, CVS Health, and AVENOVA. Specific NDCs include 70000-0457, 70677-1160, 50804-160, 41250-937, and 83324-029. UPCs include 0096295137101, 0010939958297, among others. The recall involves 245,184 bottles with lot numbers such as SU24E01, SU24E02, SU24E03, and SU24K01, with expiration dates of 5/31/26 and 9/30/26. These products were distributed nationwide in the US.

What You Should Do

Consumers should stop using the affected eye drops and contact the recalling firm, K.C. Pharmaceuticals, Inc., for instructions on returns or refunds.

Why This Matters

This recall involves a significant number of eye drop bottles across multiple brands, highlighting potential risks to eye health due to sterility concerns in over-the-counter drugs.

Source

Attributed to FDA under recall number D-0412-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA is overseeing a voluntary recall of various brands of ultra lubricating eye drops due to lack of assurance of sterility, affecting 245,184 bottles distributed nationwide in the US.
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.