Why it was recalled
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Product 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
Lot numbers, UPCs & expiration codes
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0501-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 23, 2026
- FDA report date
- May 6, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Thea Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0501-2026, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98792
- Address
- 303 Wyman St
- Code information
- Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
- Postal code
- 02451-1208
- Report date
- May 6, 2026
- Product type
- Drugs
- Recall number
- D-0501-2026
- Classification
- Class II
- Recalling firm
- Thea Pharma, Inc.
- Reason for 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 23, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2026