FDA Drug recall D-0352-2026
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp
- FDA Drug
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp by Wizcure Pharmaa Private, citing lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0352-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-31 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Wizcure Pharmaa Private |
| Distribution | US |
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0352-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.