Reported Jan 25, 2023 · Ongoing

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b)…

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?

  • Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only
  • Manufactured byAkorn, Inc., Lake Forest, Il 60045
Lot codes and dates
  • Lot

    140 of 140 codes

    • (a) 0A02B
    • 0A02D
    • 0A02C
    • 0A02A
    • 0A02E
    • EXP 12/31/2022
    • 0B60C
    • 0B46B
    • 0B60D EXP 1/31/2023
    • 0B67B
    • 0B67D
    • 0B60B
    • 0B60A
    • 0B67A
    • 0B46D
    • 0B67C
    • 0B46A
    • EXP 1/31/2023
    • 0C78B
    • 0C78D
    • 0C78C
    • EXP 2/28/2023
    • 0D11A
    • 0D11C
    • 0D11B
    • 0D11D
    • EXP 3/31/2023 0E35C
    • 0E35B
    • 0E35A
    • EXP 4/30/2023
    • 0J63B
    • 0J63C
    • EXP 8/31/2023
    • 0K02A
    • 0K02C
    • 0K02D
    • 0K02B
    • EXP 9/30/2023
    • 0L47B
    • 0L47C
    • 0L47A
    • EXP 10/31/2023
    • 1B12B
    • 1B12A
    • 1B23A
    • 1B23F
    • 1B12C
    • 1B23B
    • 1B23D
    • 1B23E
    • 1B12D
    • EXP 1/31/2024
    • 1C66C
    • 1C66A
    • EXP 2/29/2024
    • 1D93B
    • 1D93D
    • 1D93C
    • 1D99B
    • 1D99C
Amount recalled
2,369,258 tubes

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, 5:06 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.