Thea Pharma, Inc.: Ivizia, Sterile Lubricant Eye Drops (povidone 0.5%), 0.33 Fl Oz (10 Ml), Made In France
Recall Summary iVIZIA sterile lubricant eye drops (0.33 fl oz bottles) made by Thea Pharma are being recalled nationwide because the FDA found manufacturing problems that mean the company cannot guarantee the product is sterile. The product was distributed across all U.S. states and Washington, D.C.
- Recalling firm
- Thea Pharma, Inc.
- Product
- 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
- 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/1a333cd2-c7d5-4ef6-9b38-3ed9cf9b8b15