Thea Pharma, Inc.: Ivizia, Sterile Lubricant Eye Drops (povidone 0.5%), 0.33 Fl Oz (10 Ml), Made In France
Recall Summary Thea Pharma is recalling iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) in 10 mL bottles distributed nationwide because the FDA found manufacturing problems that mean the company cannot guarantee the product is sterile. The recall affects all states across the United States.
- 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/691c2934-7d70-4d4e-a285-2fe7ac20cb58