April 2026 FDA Recall Oasis Tears Pf by Oasis Medical, Inc.
D-0525-2026 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Oasis Medical, Inc. on April 27, 2026 for the product Oasis Tears Pf. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0525-2026

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.
Initiated
04-27-2026
Reported
05-20-2026
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98897
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Oasis Medical, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
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

42126-6400-1 Oasis Tears Pf Preservative-free Lubricant Eye