Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Agency
- FDA Drug
- Recall date
- Apr 23, 2026
- Status
- Ongoing
- Company
- Thea Pharma, Inc.
1. What product was recalled?
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0
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
Code or lot text: Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
- LOT
- 2026.
- LOT
- 5S30C
- LOT
- 6S57B
- LOT
- Exp Date: April 30
- LOT
- Exp Date: May 31
- LOT
- Lot# 5S30B
- LOT
- Lot# 5S31B
- RECALL-NUMBER
- D-0501-2026
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0
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 82584-700-11
Code or lot text: Lot#: 3T36B, Exp. Date October 31, 2026.
- LOT
- 2026.
- LOT
- Exp. Date October 31
- LOT
- Lot#: 3T36B
- NDC
- 82584-700
- NDC
- 82584-700-05
- NDC
- 82584-700-11
- NDC
- 82584-700-13
- RECALL-NUMBER
- D-0500-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is 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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.