iVIZIA Dry Eye Recall Over Sterility Issues

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Thea Pharma Inc. is recalling iVIZIA Dry Eye lubricant eye drops due to a lack of assurance of sterility from CGMP deviations identified by the FDA.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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iVIZIA Dry Eye Recall

What Happened

Thea Pharma, Inc. is conducting a voluntary recall of iVIZIA Sterile Lubricant Eye Drops due to a lack of assurance of sterility, resulting from CGMP deviations found by the FDA during an inspection.

Which Products Are Affected

The affected product is iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), with NDC 82584-700-11, Lot number 3T36B, and expiration date October 31, 2026. This recall applies to products distributed nationwide within the United States.

What You Should Do

Consumers should contact Thea Pharma, Inc. for instructions, as the firm initiated notification via letter. The recalling firm is located at 303 Wyman St, Waltham, MA 02451.

Why This Matters

This recall highlights potential risks associated with non-sterile eye drops, which could affect consumer safety in the United States.

Source

FDA recall notice: D-0500-2026. For more information, refer to the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Thea Pharma Inc. is recalling iVIZIA Dry Eye lubricant eye drops due to a lack of assurance of sterility from CGMP deviations identified by the FDA.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.