Home / Recalls / Thea Pharma, Inc. / D-0501-2026

D-0501-2026 Class II Ongoing

Recalled by Thea Pharma, Inc. — Waltham, MA

Recall Details

Product Type: Drugs
Report Date: May 6, 2026
Initiation Date: April 23, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

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

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.