Medications & Supplements/Topical Products

iVIZIA Lubricant Eye Drops Recalled for Lack of Sterility

Agency Publication Date: April 28, 2026

Summary

Thea Pharma, Inc. is recalling iVIZIA (povidone 0.5%) Sterile Lubricant Eye Drops due to a lack of assurance of sterility following an FDA inspection of the manufacturing facility. These eye drops, sold in 10 mL (0.33 Fl oz) bottles, were distributed nationwide through retail pharmacies and drug stores. While no injuries or infections have been reported to date, the lack of sterility in a product intended for the eyes poses a serious health risk.

Risk

A product that is not properly sterilized can introduce bacteria or other contaminants directly into the eye, which may cause serious eye infections or permanent vision loss.

What You Should Do

Check your eye drop bottles for the brand name iVIZIA or Similasan iVIZIA in 0.33 Fl oz (10 mL) containers.
Identify your lot number and expiration date on the packaging. Affected codes include iVIZIA Lot 3T36B (Exp. 10/31/2026) and Similasan iVIZIA Lots 5S30B, 5S30C (Exp. 4/30/2026), 5S31B, and 6S57B (Exp. 5/31/2026).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) (10 mL)

Variants: 0.33 Fl oz

Lot Numbers:

3T36B (Exp. October 31, 2026)

NDC:

82584-700-11

Made in France; Distributed by Thea Pharma Inc.

Product: Similasan iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) (10 mL)

Variants: 0.33 Fl oz

Lot Numbers:

5S30B (Exp. April 30, 2026)

5S30C (Exp. April 30, 2026)

5S31B (Exp. May 31, 2026)

6S57B (Exp. May 31, 2026)

NDC:

59262-700-11

Made in France; Distributed by Thea Pharma Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98792

Status: Active

Manufacturer: Thea Pharma, Inc.

Sold By: Retail pharmacies; Drug stores

Manufactured In: France, United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your eye drop bottles for the brand name iVIZIA or Similasan iVIZIA in 0.33 Fl oz (10 mL) containers.

Identify your lot number and expiration date on the packaging. Affected codes include iVIZIA Lot 3T36B (Exp. 10/31/2026) and Similasan iVIZIA Lots 5S30B, 5S30C (Exp. 4/30/2026), 5S31B, and 6S57B (Exp. 5/31/2026).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) (10 mL)

Variants: 0.33 Fl oz

Lot Numbers:

3T36B (Exp. October 31, 2026)

NDC:

82584-700-11

Made in France; Distributed by Thea Pharma Inc.

Product: Similasan iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) (10 mL)

Variants: 0.33 Fl oz

Lot Numbers:

5S30B (Exp. April 30, 2026)

5S30C (Exp. April 30, 2026)

5S31B (Exp. May 31, 2026)

6S57B (Exp. May 31, 2026)

NDC:

59262-700-11

Made in France; Distributed by Thea Pharma Inc.