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Class II · ModerateActive recall

Ivizia Dry Eye

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: 3T36B, Exp. Date October 31, 2026.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in France
Brand nameIVIZIA DRY EYE
Generic namePOVIDONE
Active ingredient(s)POVIDONE
Distributed by / forThea Pharma Inc., Waltham, MA 02451
NDC82584-700-11
Show the full FDA record
Full product labeliVIZIA, 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
Recalling firmThea Pharma, Inc.
DistributionNationwide within the United States
Recall initiated2026-04-23
Report date2026-05-06
Recall completed—
Recall numberD-0500-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWaltham MA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.