Povidone Eye Drops Recall: iVIZIA Lot 3T36B
Announced 2026-05-06 · FDA
The recall is due to lack of assurance of sterility after CGMP deviations were found by the FDA during an inspection of the manufacturer. The affected product is iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz, distributed nationwide in the United States. Lot 3T36B with expiry 10/31/2026 is included in the recall.
| Brand | 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. |
| Severity | moderate |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot#: 3T36B, Exp. Date October 31, 2026. |
WHAT YOU SHOULD DO
- Stop using any iVIZIA Sterile Lubricant Eye Drops from Lot 3T36B and discard the product.
- Check your bottle to see if it matches Lot 3T36B (Exp. 10/31/2026) and do not use if it does.
- Contact Thea Pharma Inc. or the retailer for return or refund instructions.
- If you have symptoms or concerns, contact a healthcare professional and report adverse events to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.