Akorn recalls certain Lidocaine Hydrochloride Jelly USP 2% sterile 30mL tubes due to sterility testing failures. This may affect patients using prescription pain relief.
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.
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.
Sterility testing detected turbidity (cloudiness) in the product, which may indicate contamination. This could lead to infections or other health issues if used improperly.
Prescription patients using the recalled Lidocaine Jelly for pain relief. Those with the specific lot numbers listed in the recall are most at risk.
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.
Look for the lot numbers listed in the recall: 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, 9K62A, 9K62B, 9K62C, 9M04A, 9M04B.
The recall states that sterility testing found turbidity, which may indicate contamination. The product is not safe for use as recalled.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
Check the product label for the specific lot numbers: 9J36A, 9J36B, 9J39A, 9J39B, 9J39C, 9J39D, 9J39E, 9J42B, 9J42C, 9K62A, 9K62B, 9K62C, 9M04A, 9M04B.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1495-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1495-2022 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.
