USV Private Limited recalls Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICA
Recalled October 29, 2025 · FDA recall D-0034-2026 · USV Private
Hazard
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. · FDA Class II
Units
8,952 bottles
Sold at
Nationwide within the United States
Description
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Product
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
Manufacturer(s)
USV Private Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →