iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source states this is an FDA Class II recall. The source text does not report any illnesses, injuries, or confirmed contamination—only a lack of assurance of sterility due to CGMP deviations. Per the rubric, Class II recalls without reported hospitalization typically score 2 (Moderate).
Plain-English summary
iVIZIA Dry Eye (Povidone 0.5%) sterile lubricant eye drops, distributed nationwide by Thea Pharma, Inc. in Waltham, MA, are being recalled. The affected product is the 0.33 fl oz (10 mL) bottle with lot number 3T36B and expiration date of October 31, 2026, identified by NDC 82584-700-11.
The FDA discovered current Good Manufacturing Practice (CGMP) deviations during an inspection of the manufacturer that compromised the assurance of sterility for this product. CGMP deviations indicate that manufacturing processes, controls, or documentation did not meet FDA standards required to ensure product safety and quality.
Consumers who have purchased this product should stop using it and consult with their healthcare provider if they have any concerns about their eye health.
The recalled product
- Product
- IVIZIA DRY EYE (POVIDONE)
- Brand
- IVIZIA DRY EYE
- Manufacturer
- Thea Pharma, Inc.
- Category
- Drug — Ophthalmic / Eye Care
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: 3T36B
- Exp. Date October 31
- 2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Thea Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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