Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICA
Summary
The FDA issued a Class II for Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottl by USV Private Limited. Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit..
Details
Source
Drug Recall
External ID
D-0034-2026
Action Date
2025-10-29
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 35000409, Exp. Date 01/2026
Quantity Affected: 8,952 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-09
Company
Dabhel, Daman
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (USV Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does USV Private Limited have FDA actions?
This is the only FDA action we have on record for USV Private Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0034-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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