United StatesiVIZIA and Similasan iVIZIA sterile lubricant eye drops (povidone 0.5%), 0.33 fl oz (10 mL), made in France and distributed by Thea Pharma, are recalled — affected lots: 3T36B (exp. 10/31/2026), 5S30B and 5S30C (exp. 4/30/2026), 5S31B and 6S57B (exp. 5/31/2026). The recall was initiated because FDA inspection found CGMP deviations at the manufacturer, resulting in a lack of assurance of sterility.
What's being 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
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
Recalling firm: Thea Pharma, Inc., Waltham, MA, United States.
How to identify it
Lot#: 3T36B, Exp. Date October 31, 2026. Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
The hazard
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)