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Olopatadine Hydrochloride Ophthalmic Solution 0. Recall

Olopatadine Hydrochloride Ophthalmic Solution 0... has been recalled due to failed impurities/degradation specifications: the result for 'any individual unspecified impurity' exceeds the specification limit.. Both healthcare providers and consumers may be affected by this recall. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced: October 9, 2025
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Usv private limited
Category: drug
Source agency: FDA
Announced: October 9, 2025
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot #: 35000409, Exp. Date 01/2026

#	Model
1	Lot #: 35000409, Exp. Date 01/2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1## 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 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. What to do:
2Stop using the product if your lot/model matches.
3Check the FDA notice for specifics.
4Follow remedy instructions.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: October 9, 2025
Last reviewed by RecallRadar: March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot #: 35000409, Exp. Date 01/2026.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: usv private limited recall hub and Food & Drug recall hub.