Vista Gel Hypromellose Eye Drops Recalled Nationwide Due to Sterility Concerns

Source: FDA · United States

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Wizcure Pharmaa Private Limited has issued a voluntary recall for 17,280 cartons of Vista Gel Hypromellose eye drops due to a lack of assurance of sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Wizcure Pharmaa Private Limited has initiated a voluntary recall of Vista Gel Hypromellose USP 0.3% w/v eye drops. The recall was triggered due to a lack of assurance of sterility, as the products were found to have been manufactured in a manner that does not conform to current good manufacturing practices (CGMP).

Which Products Are Affected

The recall involves the following product distributed nationwide in the United States:

  • Product Name: Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel
  • Size: 10 ml (1/3 fl. oz)
  • NDC Number: 77790-002-10
  • Brand Name: VISTA HYPROMELLOSE DRY EYE RELIEF
  • Quantity: 17,280 cartons
  • Lot Information: All lots are included in this recall.
  • Manufacturer: Wizcure Pharmaa Private Limited (Bhiwadi, India)
  • Distributor: hi-health (Scottsdale, AZ)
  • Recall Number: D-0347-2026

What You Should Do

Consumers who possess the affected eye drops should stop using the product immediately. The recalling firm initiated notification via letter on December 31, 2025. Consumers seeking information regarding returns or potential health concerns should contact their healthcare provider and the distributor, hi-health, located at 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260.

Why This Matters

Using ophthalmic products that lack assurance of sterility poses a significant risk to consumers, as contaminated eye drops can lead to serious eye infections and potential vision impairment. This Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA (Event ID: 98253).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Wizcure Pharmaa Private Limited has issued a voluntary recall for 17,280 cartons of Vista Gel Hypromellose eye drops due to a lack of assurance of sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.