CLASS III Drug recall · Reported 28 May 2014 · FDA Enforcement Report

Oasis Tears, Lubricant Eye Drops recalled by Oasis Medical

Oasis Medical is recalling Oasis Tears, Lubricant Eye Drops, distributed nationwide in the US. The recall was initiated on 14 May 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: OTM-07, Expiry: 12/2015.
Quantity recalled10,549 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1347-2014
FDA event ID
68299
Recalling firm
Oasis Medical, Glendora, CA
Classification
Class III
Status
Terminated
Recall initiated
14 May 2014
FDA classified
22 May 2014
Reported
28 May 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Labeling Errors
Drug class
Eye Drops

Timeline

14 May 2014Recall initiated by company
22 May 2014Classified by FDA+8 days
28 May 2014Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Missing Label; The label on the immediate bottle is missing.

Product as listed by the FDA

Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3.

Where it was distributed

Nationwide in US

Nationwide

Questions about this recall

Is Oasis Tears, Lubricant Eye Drops recalled?

Yes. Oasis Medical recalled Oasis Tears, Lubricant Eye Drops on 14 May 2014. The recall is Class III and its status is Terminated. Recall number D-1347-2014.

Why was it recalled?

Labeling: Missing Label; The label on the immediate bottle is missing.

Which lots are affected?

Lot #: OTM-07, Expiry: 12/2015.

Where was it sold?

Nationwide in US

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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