Class II · ModerateActive recall
Similasan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
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
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMade in France
| Distributed by / for | Thea Pharma Inc., Waltham, MA 02451 |
| NDC | 59262-700-11 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Thea Pharma, Inc. |
| Distribution | Nationwide within the United States |
| Recall initiated | 2026-04-23 |
| Report date | 2026-05-06 |
| Recall completed | — |
| Recall number | D-0501-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Waltham MA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.