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Home › FDA recalls › BioGlo Fluorescein Sodium Ophthalmic Strips USP
CLASS II · ModerateFDA

Wizcure Pharmaa Private Limited recalls BioGlo Fluorescein Sodium Ophthalmic Strips USP

📅 Dec 31, 2025 · 📍 Nationwide
Recalling company
Wizcure Pharmaa Private Limited
Product
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:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Reason
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 31, 2025
Reported
Mar 4, 2026
Distribution
Distributed Nationwide in the USA
Status
Ongoing
Quantity
184,320 containers
Lot / codes
All lots
Company location
Bhiwadi, N/A
Recall type
Voluntary: Firm initiated
Recall number
D-0352-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0352-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.