Akorn recalls all Lidocaine Hydrochloride Oral Topical Solution 2% 100mL tubes (Rx only) because the manufacturer went out of business and can no longer ensure product stability.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 2% Lidocaine Hydrochloride Oral Topical Solution 100mL tubes (prescription only) because the manufacturer went out of business and can no longer conduct stability testing. This means the product may not be safe for use as it could degrade over time.
The manufacturer went out of business and can no longer perform stability studies. This means the product's safety and effectiveness over time cannot be guaranteed, potentially leading to degradation of the medication.
Prescription users of Lidocaine Hydrochloride Oral Topical Solution 2% 100mL tubes. Those most at risk are individuals who have this medication on hand and need it for medical treatment.
Check for 2% Lidocaine Hydrochlor: 100mL tubes labeled as 'Oral Topical Solution, USP (Viscous)'. All products distributed by Akorn Operating Company LLC in the US are affected.
Look for the product name and NDC numbers on the tube label to confirm it matches the recalled items.
Talk to your healthcare provider about alternative treatments if you have this medication.
The recall states the manufacturer went out of business and can no longer ensure stability, so the product may not be safe for use.
Check for 2% Lidocaine Hydrochloride Oral Topical Solution 100mL tubes with the NDC numbers listed in the recall notice.
Contact your doctor for alternative treatment options as the manufacturer can no longer provide stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0824-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0824-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
