FDA Drug recall D-0500-2026
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 0245…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 0245… by Thea Pharma, citing lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0500-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-23 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Thea Pharma |
| Distribution | US |
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.
Identifiers
| ndc | 82584-700-05 |
|---|---|
| ndc | 82584-700-11 |
| ndc | 82584-700-13 |
| code_info | Lot#: 3T36B, Exp. Date October 31, 2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0500-2026%22
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