Home / Recalls / USV Private Limited / D-0034-2026

D-0034-2026 Class II Ongoing

Recalled by USV Private Limited — Dabhel, Daman

FDA drug recall D-0034-2026 was initiated by USV Private Limited on Oct 9, 2025 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. The recall status is ongoing. Affected quantity: 8,952 bottles.

Recall Details

Product Type: Drugs
Report Date: Oct 29, 2025
Initiation Date: Oct 9, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,952 bottles

Product Description

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 Pattern

Nationwide within the United States

Code Information

Lot #: 35000409, Exp. Date 01/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0034-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.