HIGH

BioGlo Ophthalmic Strips Recalled Over Sterility Concerns

BioGlo Fluorescein Sodium Ophthalmic Strips are recalled due to sterility issues. The recall affects 184,320 containers distributed nationwide in the USA. Consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
December 31, 2025
Hazard Level
HIGH
Brands
BioGlo, Wizcure Pharmaa Private
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Wizcure Pharmaa Private Limited or your healthcare provider for guidance. Notification method: Letter

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Product Details

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips per container. Manufactured by Omni Lens PVT. Ltd. and distributed by HUB Pharmaceuticals, LLC. Recall date is December 31, 2025.

The Hazard

The recall was initiated due to a lack of assurance of sterility. The product was not manufactured according to current good manufacturing practices.

Reported Incidents

There have been no reported incidents related to this recall. However, lack of sterility can pose serious health risks.

What to Do

Stop using the product immediately. Contact Wizcure Pharmaa Private Limited or your healthcare provider for further guidance.

Contact Information

For more details, email info@omnilens.in or visit the FDA link for the recall at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0352-2026.

Key Facts

  • Recall initiated due to sterility concerns
  • 184,320 containers affected
  • Distributed nationwide in the USA
  • Manufactured by Omni Lens PVT. Ltd.
  • Contact Wizcure Pharmaa for more information

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
All lots
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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