Akorn recalls all Levetiracetam Oral Solution 100 mg/mL (473mL) due to discontinued stability testing after the company went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Levetiracetam Oral Solution 100 mg/mL (473 mL) products because the manufacturer went out of business and could no longer perform stability testing. This means the medication may not be safe for long-term use.
The manufacturer went out of business and could no longer continue stability testing. This means the medication's safety and effectiveness over time cannot be guaranteed, potentially leading to reduced effectiveness or adverse reactions.
Prescription medication users who have the Levetiracetam Oral Solution 100 mg/mL (473 mL) product. People with seizures or epilepsy who require this medication are most at risk.
Check for the product name 'Levetiracetam Oral Solution 100 mg/mL (473 mL)' with the manufacturer Akorn, Inc. All products distributed by Akorn are affected.
Look for the product name 'Levetiracetam Oral Solution 100 mg/mL (473 mL)' and manufacturer Akorn, Inc.
The recall states the manufacturer went out of business and could no longer continue stability testing, so the safety of the product over time cannot be guaranteed.
The recall does not specify a remedy, so you should contact your healthcare provider for guidance on whether to continue using the medication.
Check for the product name 'Levetiracetam Oral Solution 100 mg/mL (473 mL)' with the manufacturer Akorn, Inc. All products distributed by Akorn 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-0816-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0816-2023 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.
