iVIZIA — Class II drug recall D-0500-2026
Ongoing recall by Thea Pharma, Inc., reported 2026-05-06, distributed nationwide. Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during
| Recall number | D-0500-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thea Pharma, Inc., Waltham, MA, United States |
| Recall initiated | 2026-04-23 |
| Classified | 2026-04-28 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, cgmp |
| NDC | 82584-0700, 82584-0700-05, 82584-0700-11, 82584-0700-13 |
| Lot numbers | 3T36B |
| Expiration dates | 2026-10-31 |
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 for recall
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0500-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.