Recalls / Class II

Class IID-0346-2026

Product

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.

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

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

H - 881, N/A, Bhiwadi, N/A N/A, India

Distribution

Quantity

5,760 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-0346-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.