Reported Jun 7, 2023 · Ongoing

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…

Akorn, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278

Is this the product you have?

  • Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only
  • Manufactured byAkorn, Inc., Lake Forest, IL 60045. ALL NDCs
Lot codes and dates
  • All Lots
Amount recalled
N/A

This recall covers 86 products

The agency filed one notice per product. You are reading one of them; the other 85 are below.

73 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.