FDA recall, , Moderate risk
iVIZIA Sterile Lubricant Eye Drops
IVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.
Summary by Recall Canary from the FDA notice
What happened
Thea Pharma, Inc., of Waltham, Massachusetts, recalled Similasan iVIZIA Sterile Lubricant Eye Drops and iVIZIA Sterile Lubricant Eye Drops nationwide within the United States. The FDA initiated the recall because of CGMP deviations found during an inspection of the manufacturer, leading to a lack of assurance of sterility. The company began the recall on April 23, 2026, and the FDA added it to its Enforcement Report on April 28, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
2 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL)
- NDC
- 59262-700-11
- Lot code
- 5S30B
- 5S30C
- 5S31B
- 6S57B
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL)
- NDC
- 82584-700-11
- Lot code
- 3T36B
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Thea Pharma, Inc.Waltham, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98792
- Recall numbers
- D-0500-2026 to D-0501-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
