United StatesOlopatadine Hydrochloride Ophthalmic Solution USP 0.1% in 5 mL (0.17 fl oz) bottles manufactured for SOLA PHARMACEUTICALS LLC (NDC 70512-0520-05), Lot #35000409, Exp. 01/2026, sold nationwide in the U.S. (8,952 bottles) is being recalled. The product was recalled because the result for “any individual unspecified impurity” exceeds the specification limit.
What's being recalled
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
Recalling firm: USV Private Limited, Dabhel, Daman, India.
How to identify it
Lot #: 35000409, Exp. Date 01/2026
The hazard
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)