HIGHFDA DRUG

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.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
December 31, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Wizcure Pharmaa Private
Product type
Ophthalmic Diagnostic Strips
Model numbers
All lots
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 31, 2025

  2. Reported by FDA DRUG

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

BioGlo Fluorescein Sodium Ophthalmic Strips are used for diagnostic purposes in eye examinations. They help in detecting corneal abrasions and other eye conditions, making them important for healthcare providers.

Why This Is Dangerous

The lack of assurance of sterility means that the product could be contaminated, posing a risk of infection to users. This is critical for products intended for use in the eye, where contamination can lead to serious complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they have used the affected product. Immediate action is required to mitigate potential health issues.

Practical Guidance

How to identify if yours is affected

  1. Look for the product name 'BioGlo Fluorescein Sodium Ophthalmic Strips' on your packaging.
  2. Verify if the product is part of the recall by checking the lot number if available.
  3. If unsure, stop using the product and consult a healthcare provider.

Where to find product info

The product name and lot number are typically found on the box or container the strips come in.

What timeline to expect

Expect a realistic timeline of 4-6 weeks for refund processing after the product is returned.

If the manufacturer is unresponsive

  • Contact Wizcure Pharmaa directly via email or phone for assistance.
  • File a complaint with the FDA if there is no response.

How to prevent similar issues

  • Check for FDA recalls before purchasing medical products.
  • Look for products that have been certified for sterility by recognized organizations.
  • Consult with healthcare providers about the safety of medical products.

Documentation advice

Keep a copy of your purchase receipt, any emails or letters from the manufacturer, and document any symptoms or issues experienced.

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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.

Key Facts

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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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