Recall
FDAHealthApril 23, 2026

Thea Pharma, Inc. — 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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 23, 2026

Nationwide within the United States

What's affected?

Product
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
Lot code
5S30B

Additional details

Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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