Bio Glo Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
Bio Glo Fluorescein Sodium Ophthalmic Strips USP were not manufactured following proper sterility standards. These diagnostic strips, distributed nationwide, may not be sterile and could pose a safety risk if used in the eye.
From the FDA notice · Read the official notice ↗
What to do
- Stop using Bio Glo Fluorescein Sodium Ophthalmic Strips immediately
- Contact your eye care provider or pharmacist for a replacement
- Do not use these strips for eye exams or diagnostic procedures
- Check NDC 17238-900-30 on your product to confirm it is affected
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 7 products — see all of them.
Details
- Units affected
- 50,400 Boxes
- Illnesses reported
- None reported
- Manufactured in
- H - 881, N/A, Bhiwadi, N/A, India
- Classification
- Class II
- Recall number
- D-0351-2026
In the FDA's words
- Description
- 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. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. All lots Distribution: Distributed Nationwide in the USA Affected quantity: 50,400 Boxes
- Hazard
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
7 products in this recall
Vista, Bio Glo and CHNaO eye products recalled for sterility
Wizcure Pharma is recalling seven eye products sold nationwide: Vista dry eye drops (Vista Tears, Vista Gel, Vista Meibo Tears and Vista Gonio), Bio Glo and BioGlo fluorescein diagnostic test strips, and CHNaO fluorescein test strips. The FDA says the products were not made under current good manufacturing practices, so the company cannot assure they are sterile. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured…D-0346-2026 · 5,760 cartons
- Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industria…D-0347-2026 · 17,280 cartons
- Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Pha…D-0348-2026 · 11,520 cartons
- Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase…D-0349-2026 · 139,104 cartons
- CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wiz…D-0350-2026 · 10,080 boxes
- Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmeda… (this page)D-0351-2026 · 50,400 Boxes
- BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahme…D-0352-2026 · 184,320 containers