Reported Jan 25, 2023 · Ongoing

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in…

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?

  • GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd
  • byAkorn, INc., Lake Forest, IL 60045
  • NDC17478-064-12
Lot codes and dates
  • Lot
    • 0C80A
    • EXP 2/28/2023
    • 0B71A
    • 1B32A
    • EXP 1/31/2023
    • 0C80B
    • EXP 2/28/2023
    • 0F68A
    • EXP 5/31/2023
    • 0G85A
    • 0G01A
    • 1G54A
    • 1G71A
    • EXP 6/30/2023
    • 0H32A
    • 0H47A
    • 1H75A
    • EXP 7/31/2023
    • 0K22A
    • EXP 9/30/2023
    • 0M90A
    • EXP 11/30/2023
Amount recalled
196,254 bottles

This recall covers 27 products

The agency filed one notice per product. You are reading one of them; the other 26 are below.

14 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations:

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Akorn, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 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.