BioGlo Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
BioGlo Fluorescein Sodium Ophthalmic Strips were not manufactured according to safety standards, raising concerns about sterility. The strips are used by eye care professionals for diagnostic eye exams. All lots distributed nationwide are affected.
From the FDA notice · Read the official notice ↗
What to do
- Stop using BioGlo Fluorescein Sodium Ophthalmic Strips (NDC 17238-900-11) immediately.
- Contact your eye doctor or clinic if you have used these strips recently.
- Do not dispose of the strips in household trash; ask your healthcare provider or pharmacist how to return or properly dispose of them.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 7 products — see all of them.
Details
- Units affected
- 184,320 containers
- Illnesses reported
- None reported
- Manufactured in
- H - 881, N/A, Bhiwadi, N/A, India
- Classification
- Class II
- Recall number
- D-0352-2026
In the FDA's words
- Description
- 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. 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: 184,320 containers
- 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…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… (this page)D-0352-2026 · 184,320 containers