BioGlo 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 BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrud…

Recall number

D-0352-2026

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

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.