Medications & Supplements/Prescription Drugs

Olopatadine Hydrochloride Ophthalmic Solution Recalled for Impurities

Agency Publication Date: October 21, 2025

Summary

USV Private Limited is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution USP 0.1%, an eye drop used to treat allergy symptoms. The recall was initiated because testing revealed an unspecified impurity that exceeds safe specification limits. This voluntary recall affects 5 mL bottles manufactured for Sola Pharmaceuticals.

Risk

The presence of impurities above the specification limit may lead to decreased drug effectiveness or unexpected side effects when applied to the eye.

What You Should Do

Check your eye drop bottle to see if it is Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% in a 5 mL (0.17 FL OZ) size with NDC 70512-0520-05.
Verify the bottle for lot number 35000409 and an expiration date of 01/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% (5 mL)by Sola Pharmaceuticals

Variants: 0.1%

Lot Numbers:

35000409 (Exp. 01/2026)

NDC:

70512-0520-05

Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97766

Status: Active

Manufacturer: USV Private Limited

Sold By: Pharmacies

Manufactured In: India

Units Affected: 8,952 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your eye drop bottle to see if it is Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% in a 5 mL (0.17 FL OZ) size with NDC 70512-0520-05.

Verify the bottle for lot number 35000409 and an expiration date of 01/2026.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.