Oasis Tears Pf Solution/ Drops
FDA Recall NDC 42126-6400
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Oasis Tears Pf (NDC 42126-6400). A significant event, classified as Class II, was initiated on Apr 27, 2026 by Oasis Medical, Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Apr 27, 2026
May 20, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98897
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Oasis Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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.
Batch or Lot Expiration Information
Lot# 1V59, Exp Date: 05/31/26
Lot# 3V12, 3V69, Exp Date: 08/31/26.
Affected Packages Involved in this Recall
42126-6400-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
