Use caution Drug recall · FDA · Published September 17, 2019

Akorn Recalls Lidocaine Jelly Due to Metal Particulate Risk

Akorn recalls 10,543 tubes of Lidocaine Hydrochloride Jelly USP due to cGMP deviations involving metal particulate matter found near the filling line.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1878-2019Drug Akorn ›

Use caution until it’s fixed

cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.

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Contact the company

Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862

✎ GovInfoNow plain-language explainer

Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2%, in 30 mL sterile tubes manufactured at its Lake Forest, IL facility. The recall was initiated because the firm identified metal particulate matter in the filling room near the tube feeder during production. Although no particulates were found inside the product itself, they were detected on the filling line. Read more at govinfonow.com/recall/37927-akorn-recalls-lidocaine-jelly-due-to-metal-particulate-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37927-akorn-recalls-lidocaine-jelly-due-to-metal-particulate-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-1878-2019

Cite this page

“Akorn Recalls Lidocaine Jelly Due to Metal Particulate Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37927-akorn-recalls-lidocaine-jelly-due-to-metal-particulate-risk. Based on FDA recall #D-1878-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1878-2019%22&limit=1).

The FDA announced on 2019-09-17 that Akorn, Inc. voluntarily recalled Lidocaine Hydrochloride Jelly USP due to cGMP deviations involving metal particulate matter found in the filling room. The recall affects 10,543 tubes distributed nationwide.

How to tell if you have it

Brand: Akorn
Product: Lidocaine Hydrochloride Jelly USP, 2%, 30 mL tubes
NDC: 17478-711-30
Lot #: 9B21A
Expiration: 1/2022

The hazard

The firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation. No particulates were identified in the product itself, but rather on the filling line.

Context

GovInfoNow's records show Akorn, Inc. has 64 other recalls on record since 2014-08-05. Other recent recalls of similar products include Sterile Lubricant Dry Eye Relief Eye Drops (2026-09-11), K.C. Pharmaceuticals Recalls Eye Drops Due to Lack of Sterility Assurance (2026-03-03), and Asclemed Lidocaine HCl Injection Recall: Risk of Contaminated Medication (2026-06-08).

How to tell if you have this one

Check if you have Lidocaine Hydrochloride Jelly USP, 2%, in 30 mL tubes manufactured by Akorn, Inc. Look for NDC 17478-711-30 and Lot #9B21A with an expiration date of January 2022.

Brand
Akorn
Category
Drug

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Sep 17, 2019Firm started the recall
Sep 24, 2019FDA classified it Class II
Oct 2, 2019Published in FDA’s Enforcement Report
Aug 1, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product distributed?

The product was distributed nationwide within the United States and Puerto Rico.

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Link to this recall

<a href="https://govinfonow.com/recall/37927-akorn-recalls-lidocaine-jelly-due-to-metal-particulate-risk">Akorn Recalls Lidocaine Jelly Due to Metal Particulate Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1878-2019 (September 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1878-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.