Drug recall D-0500-2026

Class II Ongoing reported May 6, 2026

Product

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

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.

Lots and codes

Lot#: 3T36B, Exp. Date October 31, 2026.

Recall details

Recalling firm
Thea Pharma, Inc., Waltham, MA
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
April 23, 2026

Related products