Recalls / Class II
Class IID-0349-2026
Product
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.
- Brand name
- Vista Gonio Eye Lubricant
- Generic name
- Hypromellose Ophthalmic Solution
- Active ingredient
- Hypromellose 2208 (100 Mpa.s)
- Route
- Ophthalmic
- NDC
- 77790-022
- FDA application
- M018
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recalling firm
- Firm
- Wizcure Pharmaa Private Limited
- Manufacturer
- Red Wedding LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- H - 881, N/A, Bhiwadi, N/A N/A, India
Distribution
- Quantity
- 139,104 cartons
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-31
- FDA classified
- 2026-02-25
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0349-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.