iVIZIA Dry Eye Recall Over Sterility Issues
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (974 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.