Thea Pharma, Inc.: Similasan, Ivizia, Sterile Lubricant Eye Drops (povidone 0.5%), 0.33 Fl Oz (10 Ml), Made In France
Recall Summary Similasan and iVIZIA sterile lubricant eye drops (0.33 fl oz bottles) distributed by Thea Pharma Inc. are being recalled nationwide due to manufacturing quality control problems that prevent the company from confirming the product is sterile. The FDA found manufacturing violations during an inspection of the French manufacturer. This is a Class II recall affecting all U.S. states and territories.
- Recalling firm
- Thea Pharma, Inc.
- 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
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-23
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/9de1d09b-6139-4004-b1ff-7036b4a681ef