Similasan recalled over sterility concerns

Recall date

April 23, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Thea Pharma, Inc. recalls Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: The…

Recall number

D-0501-2026

FDA classification

Class II

Brand / firm

Thea Pharma, Inc.

Sold / distributed

Nationwide within the United States

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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