Ivizia Dry Eye Solution/ Drops
FDA Recall NDC 82584-700
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ivizia Dry Eye (NDC 82584-700). A significant event, classified as Class II, was initiated on Apr 23, 2026 by Thea Pharma Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Apr 23, 2026
May 06, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98792
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Thea Pharma, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
Lot# : 3T36B, Exp. Date October 31, 2026.
Affected Packages Involved in this Recall
82584-700-05Product
82584-700-11Product
82584-700-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
