Akorn recalls 5% lidocaine ointment tubes due to stability concerns after manufacturer went out of business. All products are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 5% lidocaine ointment tubes (1 1/4 oz) that require a prescription because the manufacturer went out of business and can no longer conduct stability tests. This means the ointment 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 ointment's quality and safety over time cannot be confirmed, potentially leading to degradation.
Prescription holders of Akorn's 5% lidocaine ointment tubes (1 1/4 oz) manufactured for Hi-Techn Pharmacal Co., Inc. in Amityville, NY are affected. Patients using this ointment for medical purposes are most at risk due to potential degradation.
Check for Akorn's 5% lidocaine ointment tubes (1 1/4 oz) that require a prescription. All products manufactured for Hi-Techn Pharmacal Co., Inc. in Amityville, NY are included in this recall.
Review the product label for the manufacturer name and location to confirm it matches the recall criteria.
The recall states the manufacturer can no longer conduct stability tests, so the ointment's safety over time is uncertain. Do not use if you have concerns.
Check for Akorn's 5% lidocaine ointment tubes (1 1/4 oz) that require a prescription. All products manufactured for Hi-Techn Pharmacal Co., Inc. in Amityville, NY are included.
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to use or discard the product.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0822-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0822-2023 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.
