Reported Jan 25, 2023 · Ongoing

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL…

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?

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles

3 of 3 products

Products covered by this recall
#Product as published
1NDC 17478-288-11
2(c) 15 mL dropper bottles, NDC 17478-288-12
3Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Lot codes and dates
  • Lot

    93 of 93 codes

    • (a) 0B50A
    • 0B69A
    • EXP 1/31/2023
    • 0C74A
    • EXP 2/28/2023
    • 0D04A
    • EXP 3/31/2023
    • 0E37A
    • EXP 4/30/2023
    • 0G07A
    • 0G82A
    • EXP 6/30/2023
    • 0H26A
    • 0H28A
    • 0H53A
    • 0H36A
    • EXP 7/31/2023
    • 0J64A
    • 0J58A
    • 0J66A
    • EXP 8/31/2023
    • 0K96A
    • 0K06A
    • 0K98A
    • 0K04A
    • 0K03A
    • 0K99A
    • EXP 9/30/2023
    • 0L72A
    • EXP 10/31/2023
    • 0M81A
    • 0M85A
    • 0M80A
    • 0M84A
    • 0M82A
    • 0M83A
    • EXP 11/30/2023
    • 1A01A
    • 1A02A
    • EXP 12/31/2023
    • 1B16A
    • 1B13A
    • 1B17A
    • EXP 1/31/2024
    • 1C51A
    • EXP 2/29/2024
    • (b) 0B59A
    • EXP 1/31/2023
    • 0E49A
    • EXP 4/30/2023
    • 0G14A
    • EXP 6/30/2023
    • 0H38A
    • EXP 7/31/2023
    • 0J84A
    • EXP 8/31/2023
    • 0K05A
    • EXP 9/30/2023
    • 0L59A
    • EXP 10/31/2023
Amount recalled
1,310,324 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.

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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, 8:05 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.