FDA Drugs recall ·
Vista Tears Polyethylene Glycol 400 0.4% w/v… recall
- Recall number
- D-0346-2026
- Date
- (initiated December 31, 2025)
- Company / brand
- Wizcure Pharmaa Private Limited
H - 881, Bhiwadi, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,760 cartons
- Hazard tags
- Sterility Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0346-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.