Class II
Drug Recall: 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
USV Private Limited · October 9, 2025
Reason for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Distribution
Nationwide within the United States
States Affected
NATIONWIDE
Quantity Affected
8,952 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0034-2026
Status: ongoing
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