FDA recall D-0034-2026

USV Private Limited · Class II · drug

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2025-10-09
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dabhel, Daman, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2026