FDAHealthOctober 9, 2025
USV Private Limited — 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
⚠️ Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 9, 2025
Nationwide within the United States
What's affected?
- 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
- Brand
- USV Private Limited
- Lot code
- 35000409
Additional details
Lot #: 35000409, Exp. Date 01/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8,952 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.