FDA-Drug2026-03-04Class IIPROCESSING DEFECT
Vista Gonio Eye Lubricant recalled for sterility concerns
What this means
Vista Gonio Eye Lubricant (hypromellose ophthalmic solution) distributed by hi-health was not manufactured following required safety standards, raising concerns about sterility. All lots of this eye drop product are affected. No injuries have been reported to date.
- Stop using Vista Gonio Eye Lubricant immediately
- Do not apply the product to your eyes
- Contact your eye doctor or pharmacist for an alternative dry eye relief product
- Dispose of the bottle safely
The agency's original wording
Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
139,104 cartons
Manufactured in
H - 881, N/A, Bhiwadi, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2026Want us to check the next one for you?
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