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.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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.
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.
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.
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).
Look for the lot numbers 5S30B, 5S30C (expiring April 30, 2026) or 5S31B, 6S57B (expiring May 31, 2026) on the product label.
The FDA found quality control issues during a factory inspection, which means the eye drops might not be sterile.
Check the product label for the specific lot numbers mentioned. If you have the recalled lots, contact Thea Pharma for instructions.
The recall is for sterility risks, not immediate injury. However, using non-sterile eye drops could lead to infection.
We’ve drafted a message you can send Thea Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0501-2026 — Thea Pharma Thea Pharma Hello, I own a Thea Pharma that is covered by recall D-0501-2026 from Thea Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
