Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % Recalled by USV Private Limited Due to Failed Impurities/Degradation Specifications: The result for 'Any individual...

Date: October 9, 2025
Company: USV Private Limited
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact USV Private Limited directly.

Affected Products

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05

Quantity: 8,952 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About USV Private Limited

USV Private Limited has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report