Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.
What this means for you
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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is based on manufacturing deviations that resulted in loss of sterility assurance rather than confirmed contamination. Per the rubric, Class II recalls without reported illness or injury typically score 2 (Moderate).
Plain-English summary
Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL) bottles distributed nationwide in the United States. The recall affects the following lot numbers and expiration dates: Lot# 5S30B and 5S30C (Exp Date: April 30, 2026), and Lot# 5S31B and 6S57B (Exp Date: May 31, 2026).
The recall was initiated because the FDA identified current Good Manufacturing Practice (CGMP) deviations during an inspection of the manufacturer. These deviations resulted in a lack of assurance that the product meets sterility standards required for eye drops.
Consumers who have purchased affected lots should stop using the product. Consult with a healthcare provider or pharmacist for guidance. Consumers with questions about the recall can contact Thea Pharma, Inc. at the address listed on the product packaging.
The recalled product
- Product
- Similasan, 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 59262-700-11
- Manufacturer
- Thea Pharma, Inc.
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- sterility-assurance
- cgmp-deviation
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 (8)
- Lot# 5S30B
- 5S30C
- Exp Date: April 30
- 2026
- Lot# 5S31B
- 6S57B
- Exp Date: May 31
- 2026.
Distribution
Distributed nationwide across the United States.