Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief...

FDA Recall #D-0346-2026 — Class II — December 31, 2025

Recall #D-0346-2026 Date: December 31, 2025 Classification: Class II Status: Ongoing

Product Description

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.

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

5,760 cartons

Distribution

Distributed Nationwide in the USA

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated