Drug recall: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma…

Class II FDA enforcement event 98792. Recall start date: 23 Apr 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Class II, in the words of FDA

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

Thea Pharma, Inc. started this drug recall on 23 Apr 2026. The firm address in the FDA record is in Waltham, MA. FDA put the recall in Class II. FDA event 98792 has 2 product records. The first FDA enforcement report date is 6 May 2026. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide within the United States

Recalling firm

Thea Pharma, Inc., Waltham, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 98792: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0500-2026	iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11		Class II	Ongoing	6 May 2026
D-0501-2026	Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11		Class II	Ongoing	6 May 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2026: 234
Share of these events in Class II: 74%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 2

Other events of the firm

Other FDA enforcement events of Thea Pharma, Inc.
Initiated	Product (first record)	Type	Class	Records
5 Mar 2024	Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 0242 Event 94146	Drug	Class II	1

Official channels

FDA enforcement report D-0500-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98792. https://recallregister.com/fda/ii/98792/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide within the United States
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2026 have the same class?: 74% of the 234 drug events that started in 2026 are in Class II.
How many FDA recalls does Thea Pharma, Inc. have?: Thea Pharma, Inc. is the recalling firm in 2 enforcement events on this register. This event is 1 of them.