Vista Gonio Eye Lubricant Recall Issued Due to Sterility Concerns
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Wizcure Pharmaa Private Limited is recalling 139,104 cartons of Vista Gonio Eye Lubricant because the product lacks assurance of sterility and failed to meet manufacturing standards.
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.
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What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of Vista Gonio Eye Lubricant. The recall was prompted by 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 affects the following product distributed nationwide in the USA:
- Product Name: Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops, Dry Eye Relief)
- Size: 15 ml (1/2 fl. oz.)
- NDC Number: 77790-022-15
- Recall Number: D-0349-2026
- Quantity: 139,104 cartons
- Code Information: All lots are included in this recall.
- Manufacturer: Wizcure Pharmaa Pvt. Ltd., Bhiwadi, India
- Distributor: hi-health, Scottsdale, AZ
What You Should Do
Consumers should immediately stop using the affected eye lubricant. The recall was initiated via letter notification. For further information regarding returns or refunds, consumers should contact the distributor, hi-health, or the point of purchase.
Why This Matters
Sterility is a critical requirement for ophthalmic products. A lack of sterility assurance means the product may be contaminated, which poses a serious risk of eye infections or other vision-related injuries to consumers.
Source
This information is based on an official report from the FDA.
Original source: FDA Official Notice ↗
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