BioGlo Fluorescein Sodium Ophthalmic Strips USP recall
FDA recall D-0352-2026 · initiated Dec 31, 2025
Wizcure Pharmaa Private Limited recalled BioGlo Fluorescein Sodium Ophthalmic Strips USP in Dec 2025 — an FDA Class II recall (D-0352-2026) because Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 184,320 containers
Details
- 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.
- Recalling company
- Wizcure Pharmaa Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Dec 31, 2025
- FDA report date
- Mar 4, 2026
Frequently asked
- Was BioGlo Fluorescein Sodium Ophthalmic Strips USP recalled?
- Wizcure Pharmaa Private Limited recalled BioGlo Fluorescein Sodium Ophthalmic Strips USP in Dec 2025 — an FDA Class II recall (D-0352-2026) because Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BioGlo Fluorescein Sodium Ophthalmic Strips USP recalled?
- Per the FDA enforcement record, the reason for recall D-0352-2026 was: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Is a recalled BioGlo Fluorescein Sodium Ophthalmic Strips USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of BioGlo Fluorescein Sodium Ophthalmic Strips USP are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — All lots. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0352-2026.