FDA recall record

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP recall — FDA D-0349-2026

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Class IIclassification
D-0349-2026official record ID
Mar 4, 2026report date

Recall record at a glance

Official recordD-0349-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmWizcure Pharmaa Private Limited
Report dateMar 4, 2026
Recall initiation dateDec 31, 2025
Quantity139,104 cartons
LocationBhiwadi, N/A, India

Official product description

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

Why the product was recalled

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Distribution information

Distributed Nationwide in the USA

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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