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FDA · Drugs ·

iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) recall

Thea Pharma, Inc. recalled iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) on May 6, 2026 because of lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. It was sold nationwide.

Why it was recalled

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's recalled

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

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Thea Pharma, Inc., Waltham, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0500-2026
Source
U.S. Food and Drug Administration

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