Akorn recalls 2% Lidocaine HCl Jelly USP 5mL tubes due to stability concerns after the manufacturer closed. All products are affected. No remedy provided.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 2% Lidocaine HCl Jelly USP 5mL tubes (Rx only) because the manufacturer went out of business and can no longer ensure product stability. This means the medication may not be safe to use as intended.
The manufacturer closed and can no longer conduct stability studies, meaning the product's safety and effectiveness cannot be verified. This could lead to medication failure or adverse effects if used without proper quality assurance.
Prescription users of the Lidocaine HCl Jelly USP 5mL tubes who purchased them from any source. People with medical conditions requiring this medication are most at risk.
Check for Akorn, Inc. manufactured 2% Lidocaine HCl Jelly USP 5mL tubes (Rx only) with any NDC number. All lots and all products are affected.
Identify if you have the Akorn, Inc. manufactured 2% Lidocaine HCl Jelly USP 5mL tubes (Rx only) with any NDC number.
The manufacturer went out of business and can no longer continue stability studies, so the product's safety and effectiveness cannot be verified.
The recall notice does not provide any remedy or action steps.
Check for Akorn, Inc. manufactured 2% Lidocaine HCl Jelly USP 5mL tubes (Rx only) with any NDC number. All lots and all products are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0823-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0823-2023 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.
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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.
