Recalls / Class II
Class IID-0034-2026
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
- Affected lot / code info
- Lot #: 35000409, Exp. Date 01/2026
Why it was recalled
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Recalling firm
- Firm
- USV Private Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- H-13, 16, 16a, 17, 18, 19, 20, 21 & E-22, Oidc, Mahatma Gandhi Udyog Nagar, Dabhel, Daman, N/A, India
Distribution
- Quantity
- 8,952 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-10-09
- FDA classified
- 2025-10-20
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0034-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.