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 #: 35000409Exp. 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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