FDAFDA · Food and drugs·Recall number D-0034-2026
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
Published October 29, 2025 · Recall initiated: October 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- USV Private Limited
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 35000409, Exp. Date 01/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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