Wizcure Pharmaa Recalls Bio Glo Fluorescein Sodium Ophthalmic Strips Due to Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Wizcure Pharmaa Private Limited is recalling 50,400 boxes of Bio Glo Fluorescein Sodium Ophthalmic Strips USP nationwide due to manufacturing concerns and lack of sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of Bio Glo Fluorescein Sodium Ophthalmic Strips USP. The recall was issued due to a lack of assurance of sterility, as the products were not manufactured in conformance with current good manufacturing practices (CGMP).
Which Products Are Affected
The recall includes all lots of the following product:
- Product Name: Bio Glo Fluorescein Sodium Ophthalmic Strips USP
- Packaging: 300 diagnostic strips per box
- NDC Number: 17238-900-30
- Quantity: 50,400 boxes
- Manufacturer: Omni Lens Pvt Ltd (Ahmedabad, India)
- Distributor: HUB Pharmaceuticals, LLC (Scottsdale, AZ)
These products were distributed nationwide throughout the United States.
What You Should Do
Healthcare professionals and consumers are advised to stop using the affected ophthalmic strips immediately. The firm initiated the recall via letter notification. For further information regarding the return of the product or to address safety concerns, consumers should contact the distributor, HUB Pharmaceuticals, LLC, or the recalling firm, Wizcure Pharmaa Private Limited.
Why This Matters
Sterility is a critical safety requirement for ophthalmic products. Using diagnostic strips that do not meet sterility standards can lead to serious eye infections or other health complications for patients.
Source
Information provided by the FDA under recall number D-0351-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.