Thea Pharma: Multiple Sterile Lubricant Eye Drops
Thea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
Stop using the recalled iVIZIA Sterile Lubricant Eye Drops immediately. Contact Thea Pharma Inc. for instructions on returning the product and obtaining a refund or replacement.
Why it was recalled
Thea Pharma is recalling iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) due to a lack of assurance of sterility, stemming from CGMP deviations found during an FDA inspection of the manufacturer. The recall includes the 0.33 Fl oz (10 mL) size, as well as Similasan-branded iVIZIA eye drops.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | NDC / UPC | Recall # |
|---|---|---|---|
| Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL) | 5S30B, 5S30C, 2026, 5S31B, 6S57B | NDC 59262-700-11 | D-0501-2026 |
| iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL) | 3T36B, 2026 | NDC 82584-700-11 | D-0500-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-08-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification