Bio Glo Fluorescein Sodium Ophthalmic Strips USP recalled over sterility concerns

Recall date

December 31, 2025

Source

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

Official notice title

Wizcure Pharmaa Private Limited recalls Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi,…

Recall number

D-0351-2026

FDA classification

Class II

Brand / firm

Wizcure Pharmaa Private Limited

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

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

What was recalled

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.