Oasis Tears PF recall
FDA recall D-0525-2026 · initiated Apr 27, 2026
Oasis Medical, Inc. recalled Oasis Tears PF in Apr 2026 — an FDA Class II recall (D-0525-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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.
- Recalling company
- Oasis Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 27, 2026
- FDA report date
- May 20, 2026
Frequently asked
- Was Oasis Tears PF recalled?
- Oasis Medical, Inc. recalled Oasis Tears PF in Apr 2026 — an FDA Class II recall (D-0525-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Oasis Tears PF recalled?
- Per the FDA enforcement record, the reason for recall D-0525-2026 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.
- Is a recalled Oasis Tears PF dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Oasis Tears PF are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0525-2026.