The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0525-2026·Announced 2026-05-20

Oasis Tears PF Lubricant Eye Drops Recalled for Sterility Assurance

Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall with a sterility assurance failure for an ophthalmic drug product. The lack of sterility assurance in a product intended for direct application to the eye presents a risk of serious harm, meeting the Severe criterion.

Plain-English summary

Oasis Medical, Inc. is recalling Oasis Tears PF (Glycerin) Preservative-Free Lubricant Eye Drops, 10mL bottles, NDC 42126-6400-1. The affected lot numbers are 1V59 (expiration date 05/31/26) and 3V12 and 3V69 (expiration date 08/31/26). The product is distributed nationwide in the United States.

The recall was initiated out of an abundance of caution following FDA observations noted during a recent inspection. The agency determined there is a lack of assurance of sterility for this product.

Consumers who have this product should stop using it. Patients with questions about their treatment should consult their healthcare provider or pharmacist.

The recalled product

Product
OASIS TEARS PF (GLYCERIN)
Brand
OASIS TEARS PF
Manufacturer
Oasis Medical, Inc.
Category
Drug — Ophthalmic / Eye Drops
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot # 1V59
  • Exp Date: 05/31/26
  • Lot # 3V12
  • 3V69
  • Exp Date: 08/31/26.

Distribution

Distributed nationwide across the United States.

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