Quick Facts at a Glance
- Recall Date
- December 31, 2025
- Hazard Level
- HIGH
- Brands
- C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS, Vistamerica USA
- 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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS, Vistamerica USA
- Product type
- Fluorescein Sodium Ophthalmic Strips
- Model numbers
- All lots
- UPC codes
- 83851-100, 83851-100-10, 83851-100-30, 83851-100-05
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 31, 2025
Reported by FDA DRUG
March 4, 2026
RecallRadar source check
March 11, 2026
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
Fluorescein Sodium Ophthalmic Strips are used in medical settings for diagnostics in eye examinations. They help detect corneal abrasions and other eye conditions, making them essential for healthcare providers.
Why This Is Dangerous
The lack of sterility assurance means that these strips could introduce bacteria or other pathogens into the eye, leading to serious infections and complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks from potential infections. Immediate cessation of product use is necessary, which may lead to inconvenience for healthcare providers and patients.
Practical Guidance
How to identify if yours is affected
- Check packaging for NDC numbers 83851-100-10 or 83851-100-30.
- Verify if the product was purchased within the specified timeline.
- Look for any signs of contamination or damage to the packaging.
Where to find product info
NDC numbers and other identifiers can typically be found on the product packaging or box.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the company.
- Reach out to the FDA for further assistance.
- Consider filing a complaint with consumer protection agencies.
How to prevent similar issues
- Only purchase ophthalmic products from reputable manufacturers.
- Check for FDA approval and sterility certifications before use.
- Consult healthcare professionals for recommendations on safe products.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The recalled products include Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged in 100-count boxes (NDC 83851-100-10) and 300-count boxes (NDC 83851-100-30). These products were manufactured by Wizcure Pharmaa PVT. LTD in India and distributed nationwide in the USA.
Key Facts
- Recall date: December 31, 2025
- Report date: March 4, 2026
- Type: Fluorescein Sodium Ophthalmic Strips, 1mg
- Quantity recalled: 10,080 boxes
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Safety Guide
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