CLASS II ONGOING Drug recall · Reported 20 May 2026 · FDA Enforcement Report
Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile recalled
Oasis Medical is recalling Oasis Tears PF, Preservative-Free Lubricant Eye Drops/, Sterile, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0525-2026
- FDA event ID
- 98897
- Recalling firm
- Oasis Medical, Glendora, CA
- Brand
- Oasis Tears Pf
- Manufacturer
- OASIS Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Apr 2026
- FDA classified
- 8 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 27 Apr 2026 | Recall initiated by company | |
| 8 May 2026 | Classified by FDA | +11 days |
| 20 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Which lots are affected?
Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Dry Eye Relief Lubricant Eye Drops, (Glycerin recalledEquate Eye Drops Dry Eye Relief | K.C. Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |