Thea Pharma, Inc. recalls iVIZIA
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Apr 23, 2026
- Reported
- May 6, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Lot / codes
- Lot#: 3T36B, Exp. Date October 31, 2026.
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0500-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0500-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.