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Medium risk Drugs & MedicationsClass II

BioGlo Fluorescein Strips Recall

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III

Updated December 31, 2025

BioGlo Fluorescein Sodium Ophthalmic Strips USP (100-count) were manufactured without sterility assurance and may not meet safety standards. These diagnostic eye strips should not be used if you have concerns about their safety.

Is the Wizcure Pharmaa Private Limited recalled? Yes. This product was recalled by FDA on December 31, 2025. Details below.

What is recalled

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips (NDC 17238-900-11), manufactured by Omni Lens PVT. Ltd. in Ahmedabad, India, and distributed by HUB Pharmaceuticals, LLC (Scottsdale, Arizona).

Am I affected

You're affected if you have this product: look for BioGlo Fluorescein Sodium Ophthalmic Strips USP in a box of 100 strips with NDC code 17238-900-11. If you use fluorescein strips for eye exams, check your supply.

What to do right now

Stop using this product. Return the unused strips to your healthcare provider, pharmacy, or the manufacturer (HUB Pharmaceuticals, LLC, Scottsdale, AZ) for a refund or replacement. Contact your eye care provider if you have used these strips and have concerns.

The hazard

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

Brands affected

Wizcure Pharmaa Private Limited
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0352-2026
Classification
Class II
Recalled
December 31, 2025
Read the official notice

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