Oasis Tears PF Eye Drops Recall Issued for Sterility Concerns

Source: FDA · United States

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Oasis Medical, Inc. is voluntarily recalling specific lots of Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility.

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

This notice was issued by FDA on June 2, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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

Oasis Medical, Inc. initiated a voluntary recall of Oasis Tears PF eye drops out of an abundance of caution following FDA observations during a recent inspection of Excelvision. The recall is classified as Class II.

Which Products Are Affected

  • Product: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile
  • NDC: 42126-6400-1
  • Lots: #1V59 (Exp: 05/31/26); #3V12 and #3V69 (Exp: 08/31/26)
  • Distribution: Nationwide within the United States
  • Recall Number: D-0525-2026

What You Should Do

Consumers should stop using the affected product. Contact information for returns or further guidance is available from the recalling firm, Oasis Medical, Inc.

Why This Matters

This Class II recall addresses a potential lack of sterility assurance for an ophthalmic product distributed nationwide.

Source

FDA recall D-0525-2026 (report date 20260520)

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Oasis Medical, Inc. is voluntarily recalling specific lots of Oasis Tears PF preservative-free lubricant eye drops nationwide due to 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.