Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recall: Impurity Out of Spec
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810…
Why was Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled?
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 35000409, Exp. Date 01/2026
- Product
- Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810…
- Recalling firm
- USV Private Limited
- Quantity
- 8,952 bottles
- Distribution
- Nationwide within the United States
- Recall date
- October 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)