Recall of Sterile Eye Drops by K.C. Pharmaceuticals Due to Sterility Concerns

Source: FDA · United States

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K.C. Pharmaceuticals, Inc. is recalling 74,016 bottles of certain eye drops nationwide due to a lack of assurance of sterility, affecting products distributed under Rugby and Walgreens brands.

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 voluntarily recalling certain batches of eye drops due to a lack of assurance of sterility.

Which Products Are Affected

The affected products are STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), in 0.5 fl oz (15 mL) bottles. Specifically:

  • a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94
  • b) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 A total of 74,016 bottles are affected, with lot numbers SY24K01 and SY24K02, and an expiration date of September 30, 2026. The recall applies nationwide in the United States and is identified by recall number D-0415-2026.

What You Should Do

Consumers should immediately stop using the affected eye drops and contact K.C. Pharmaceuticals, Inc. for instructions on returns or refunds. The firm is located at 3420 Pomona Blvd, Pomona, CA 91768-3236.

Why This Matters

This recall highlights potential risks associated with non-sterile eye drops, which could affect consumer safety. Ensuring sterility in drug products is essential to prevent possible health complications.

Source

FDA Recall Notice: Attribution to FDA, Recall Number D-0415-2026

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 74,016 bottles of certain eye drops nationwide due to a lack of assurance of sterility, affecting products distributed under Rugby and Walgreens brands.
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.