BioGlo Fluorescein Sodium Ophthalmic Strips USP — Class II drug recall D-0352-2026
Ongoing recall by Wizcure Pharmaa Private Limited, reported 2026-03-04, distributed nationwide. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufactu
| Recall number | D-0352-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wizcure Pharmaa Private Limited, Bhiwadi, N/A, India |
| Recall initiated | 2025-12-31 |
| Classified | 2026-02-25 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 184,320 containers |
| Reason classes | sterility, cgmp |
| NDC | 17238-0900-11 |
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.
Reason for recall
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0352-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.