FDAFDA · Food and drugs·Recall number D-0501-2026
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
Published May 6, 2026 · Recall initiated: April 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Thea Pharma, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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