Wizcure Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
Wizcure Fluorescein Sodium Ophthalmic Strips (1mg) were not manufactured following proper sterilization standards. These strips are used by eye care professionals to examine the eye surface. Because sterility cannot be assured, there is a potential risk of contamination.
From the FDA notice · Read the official notice ↗
What to do
- Stop using the product immediately if you have it
- Contact your eye doctor or pharmacy if you recently used these strips
- Do not use any boxes with NDC 83851-100-10 or 83851-100-30
- Check with your eye care provider about safe alternatives
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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 Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 7 products — see all of them.
Details
- Units affected
- 10,080 boxes
- Illnesses reported
- None reported
- Manufactured in
- H - 881, N/A, Bhiwadi, N/A, India
- Classification
- Class II
- Recall number
- D-0350-2026
In the FDA's words
- Description
- 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 Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, 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: 10,080 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… (this page)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…D-0352-2026 · 184,320 containers