Preservative-Free Lubricant Eye Drops Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Oasis Tears PF, preservative-free lubricant eye drops, 10mL/0.34 Fl oz. The affected batches have been identified as Lot 1V59 (expiration May 31, 2026) and Lots 3V12 and 3V69 (expiration August 2026).
• The recall was initiated by Oasis Medical, Inc due to the lack of sterility assurance, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Lubricant eye drops are used to relieve burning, irritation, and discomfort caused by dry eyes.

The FDA has issued a Class II recall for Oasis Tears PF, preservative-free lubricant eye drops, 10mL/0.34 Fl oz. This medication is manufactured and distributed nationwide by Oasis Medical, Inc. The branch in Glendora, California is the one recalling the drug. The recall was initiated on April 27, 2026, and received a Class II classification on May 8, 2026.

The recall was initiated due to the lack of assurance of sterility, particularly for Lot 1V59 and Lots 3V12 and 3V69, which expire on May 31, 2026 and August 31, 2026, respectively. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is low. Oasis Medical sent out a public notice via letter; no public press release has been issued for this recall.

Lubricant eye drops, also known as artificial tears, are used to treat dry eyes by adding moisture to relieve burning, irritation, and discomfort. Pharmacists should identify and quarantine Lots 1V59, 3V12, and 3V69, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. May 20, 2026. Accessed May 20, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220111