Wizcure Pharmaa Recalls Fluorescein Sodium Ophthalmic Strips Over Sterility Concerns
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Wizcure Pharmaa Private Limited is recalling 10,080 boxes of Fluorescein Sodium Ophthalmic Strips distributed across the U.S. due to manufacturing practices that failed to ensure product sterility.
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 "medium" 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.
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What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of Fluorescein Sodium Ophthalmic Strips, USP 1mg. The recall was prompted by a lack of assurance of sterility, as the products were not manufactured in accordance with current good manufacturing practices (CGMP). This Class II recall was officially classified by the FDA on February 25, 2026.
Which Products Are Affected
The recall includes all lots of the following products distributed nationwide in the USA:
- Product Name: CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg
- Packaging and NDC Numbers:
- 100-count box (NDC 83851-100-10)
- 300-count box (NDC 83851-100-30)
- Manufacturer: Wizcure Pharmaa Private Limited, Bhiwadi, India
- Distributor: Vistamerica USA, Prescott, AZ
- Total Quantity: 10,080 boxes
What You Should Do
Healthcare providers and consumers should immediately stop using the affected ophthalmic strips. The firm initiated the recall via notification letters sent to distributors and customers. For further information regarding returns or specific lot inquiries, contact the manufacturer or the distributor, Vistamerica USA, located in Prescott, Arizona.
Why This Matters
Ophthalmic products must be sterile to prevent the risk of eye infections or other serious ocular complications. The failure to follow good manufacturing practices creates a potential safety risk for patients using these diagnostic strips during eye examinations.
Source
Information provided by the FDA. Recall Number: D-0350-2026.
Original source: FDA Official Notice ↗
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