Akorn recalls Lidocaine Hydrochloride Jelly USP 2% products with CGMP deviations. Products sold in 5mL and 30mL tubes, Rx only. Check NDC codes and expiration dates for affected lots.
CGMP Deviations:
Akorn is recalling Lidocaine Hydrochloride Jelly USP 2% products due to manufacturing quality control issues. This recall affects specific lots of 5mL and 30mL tubes that were sold with expiration dates up to 2025. The hazard is a CGMP deviation, which means the product may not meet safety standards.
CGMP deviations indicate that the manufacturing process did not meet the required quality standards. This could mean the product is not safe for medical use, potentially leading to adverse effects if used improperly.
People who have the specific 5mL or 30mL tubes with the listed NDC codes and expiration dates are affected. Prescribers and patients using these products for medical purposes are most at risk.
Check for NDC codes 17478-711-10 (5mL tubes) or 17478-711-30 (30mL tubes) on the product packaging. Look for expiration dates listed in the recall notice, which range from December 2022 to February 2025.
Identify the NDC code and expiration date on your Lidocaine Hydrochloride Jelly USP 2% product to see if it matches the recalled lots listed in the notice.
The product was recalled due to CGMP deviations, meaning the manufacturing process did not meet quality standards, which could affect safety.
Check the NDC code on the product packaging. The affected products have specific NDC codes (17478-711-10 or 17478-711-30) and expiration dates listed in the recall notice.
The recall notice does not specify a remedy, so contact Akorn directly for guidance on next steps.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0143-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0143-2023 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.
