Unrated Drug recall · FDA · Published August 31, 2022

Akorn recalls Lidocaine Jelly: Sterility Testing Issues

Akorn recalls certain Lidocaine Hydrochloride Jelly USP 2% sterile 30mL tubes due to sterility testing failures. This may affect patients using prescription pain relief.

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

🇺🇸 FDA recall #D-1495-2022Drug Akorn ›

Recall notice

cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

Take action

Contact the company

Recalling firmAkorn, Inc.5605 Centerpoint Ct Ste A · Gurnee, IL 60031-5278

✎ GovInfoNow plain-language explainer

Akorn is recalling specific lots of Lidocaine Hydrochloride Jelly USP 2% sterile 30mL tubes because sterility testing found turbidity. This could mean the product is contaminated and unsafe for medical use. Read more at govinfonow.com/recall/34333-akorn-recalls-lidocaine-jelly-sterility-testing-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/34333-akorn-recalls-lidocaine-jelly-sterility-testing-issues · Updated August 18, 2026 · FDA enforcement record: FDA #D-1495-2022

Cite this page

“Akorn recalls Lidocaine Jelly: Sterility Testing Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34333-akorn-recalls-lidocaine-jelly-sterility-testing-issues. Based on FDA recall #D-1495-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1495-2022%22&limit=1).

The FDA announced on August 31, 2022, that Akorn, Inc. voluntarily recalled Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tubes due to cGMP deviations. The recall affects 82,689 tubes distributed nationwide in the USA.

How to tell if you have it

Brand: Akorn
Product: Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube
NDC: 17478-711-31
Lots: 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C (Exp 8/31/2022); 9K62A, 9K62B, 9K62C (Exp 9/30/2022); 9M04A, 9M04B (Exp 11/30/2022)
Distribution: USA nationwide

The hazard

The recall was initiated due to cGMP deviations involving turbidity discovered in Artificial Tears Ointment during sterility testing. The scope of the issue expanded to include other lots and products which potentially share the same root cause.

Context

GovInfoNow's records show Akorn, Inc. has had 64 other recalls on record since August 5, 2014. Recent brand recalls include Akorn Rifampin Capsules 300mg (April 26, 2023) and Akorn Atropine Sulfate Ophthalmic Solution 1% (January 30, 2023). Other recent recalls of similar products include Huons Lidocaine HCl Injection (April 2, 2026) and K.C. Pharmaceuticals Eye Drops (March 3, 2026).

How to tell if you have this one

Check the product label for the specific lot numbers: 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, 9K62A, 9K62B, 9K62C, 9M04A, 9M04B. The product is a sterile 30mL tube for prescription use only.

Brand
Akorn
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
USA nationwide

Recall number	Product, codes & lots	Quantity
D-1495-2022	Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31; Lot # 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, Exp 8/31/2022; 9K62A, 9K62B, 9K62C, Exp 9/30/2022; 9M04A, 9M04B, Exp 11/30/2022	82,689 tubes
D-1496-2022	Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35; Lot#: 9J58A, 9J58B, Exp 8/31/2022	48,636 tubes

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot numbers listed in the recall: 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, 9K62A, 9K62B, 9K62C, 9M04A, 9M04B.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Aug 31, 2022Firm started the recall
Sep 6, 2022FDA classified it Class II
Sep 14, 2022Published in FDA’s Enforcement Report
Jun 18, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/34333-akorn-recalls-lidocaine-jelly-sterility-testing-issues">Akorn recalls Lidocaine Jelly: Sterility Testing Issues (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-1495-2022 (August 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1495-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.