Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 1...

FDA Recall #D-0349-2026 — Class II — December 31, 2025

Recall #D-0349-2026 Date: December 31, 2025 Classification: Class II Status: Ongoing

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.

Reason for Recall

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

Recalling Firm

Wizcure Pharmaa Private Limited — Bhiwadi, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

139,104 cartons

Distribution

Distributed Nationwide in the USA

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated