Drug & medication recalls Moderate risk

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

Recall date
October 9, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0034-2026
FDA classification
Class II
Brand / firm
USV Private Limited
Sold / distributed
Nationwide within the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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

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