Reported Oct 29, 2025 · Ongoing

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA…

USV Private Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: USV Private Limited · H-13, 16, 16a, 17, 18, 19, 20, 21 & E-22, Oidc, Mahatma Gandhi Udyog Nagar · Dabhel, Daman · N/A

Is this the product you have?

  • Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles
  • Manufactured forSOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
Lot codes and dates
    • Lot #: 35000409
    • Exp. Date 01/2026
Amount recalled
8,952 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:23 PM UTC

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