Thea Pharma Similasan Eye Drops Recall: Sterility Risk from FDA Inspection
Thea Pharma recalls sterile lubricant eye drops (Povidone 0.5%) due to FDA finding CGMP deviations during inspection. Products made in France with specific lots may pose sterility risks.
Lower-risk recall
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Contact the company
What happened, in plain English
Thea Pharma is recalling sterile lubricant eye drops that were made in France due to FDA finding manufacturing quality issues. Using these products could risk infection since they're not properly sterile. Read more at govinfonow.com/recall/31336-thea-pharma-similasan-eye-drops-recall-sterility-risk-from-fda.
Source Summary by GovInfoNow · govinfonow.com/recall/31336-thea-pharma-similasan-eye-drops-recall-sterility-risk-from-fda · Updated August 17, 2026 · FDA enforcement record: FDA #D-0501-2026
Cite this page
“Thea Pharma Similasan Eye Drops Recall: Sterility Risk from FDA Inspection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31336-thea-pharma-similasan-eye-drops-recall-sterility-risk-from-fda. Based on FDA recall #D-0501-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0501-2026%22&limit=1).
Why it’s dangerous
The FDA found quality control problems during a factory inspection. This means the eye drops might not be sterile, which could lead to eye infections if used. However, the risk is low since the issue was caught early and only specific lots were affected.
Who’s affected
People who own or use the recalled eye drops, especially those with sensitive eyes or medical conditions requiring sterile eye care. Those with compromised immune systems may be at higher risk.
How to tell if you have this one
Check for the product name 'Similasan', 'iVIZIA', or 'Sterile Lubricant Eye Drops (Povidone 0.5%)'. Look for lot numbers 5S30B, 5S30C (expiring April 30, 2026) or 5S31B, 6S57B (expiring May 31, 2026).
- Brand
Thea Pharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0500-2026 | 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; Lot#: 3T36B, Exp. Date October 31, 2026. | — | 82584-700-05, 82584-700-11, 82584-700-13 |
| 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; Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026. | — | — |
What to do — step by step
Check Product Details
Look for the lot numbers 5S30B, 5S30C (expiring April 30, 2026) or 5S31B, 6S57B (expiring May 31, 2026) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 13 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0501-2026 (April 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0501-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.