USV Private Limited: Drug Recall
Recall #D-0034-2026 · 10/09/2025
Class II: Risk
Recall Details
- Recall Number
- D-0034-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- USV Private Limited
- Status
- Ongoing
- Date Initiated
- 10/09/2025
- Location
- Dabhel, Daman, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,952 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
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
Distribution Pattern
Nationwide within the United States
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.