Quick Facts at a Glance
- Recall Date
- April 23, 2026
- Hazard Level
- HIGH
- Brand
- Thea Pharma
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Thea Pharma
- Model numbers
- Lot# 5S30B, 5S30C, Exp Date: April 30, 2026, Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 23, 2026
Reported by FDA DRUG
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Thea Pharma, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full Description
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. Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.. Classification: Class II. Distribution: Nationwide within the United States
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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