Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical,
Summary
The FDA issued a Class II for Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, S by Oasis Medical, Inc.. Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspecti.
Details
Source
Drug Recall
External ID
D-0525-2026
Action Date
2026-05-20
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.
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.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-27
Company
Glendora, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Oasis Medical, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oasis Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oasis Medical, Inc. have FDA actions?
Oasis Medical, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0525-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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