Akorn recalls all 118mL Levocarnitine Oral Solution bottles (Rx only) due to stability concerns after the manufacturer closed. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 118mL Levocarnitine Oral Solution bottles (prescription-only) because the manufacturer went out of business and could no longer test product stability. This means the medication may not be safe for use after the recall date.
The manufacturer closed and could no longer conduct stability studies, meaning the medication's safety and effectiveness could be compromised over time. Without ongoing testing, there's no guarantee the product remains safe for use.
Prescription patients who have the 118mL Levocarnitine Oral Solution bottles from Akorn. Patients using this medication for medical conditions are most at risk if they don't follow the recall instructions.
Check for 118mL bottles labeled 'Levocarnitine Oral Solution, USP, Rx Only' from Akorn. All product lots and National Drug Codes (NDCs) are affected.
Identify if you have the 118mL Levocarnitine Oral Solution bottles from Akorn, which are prescription-only.
The official notice does not provide any remedy steps.
The manufacturer went out of business and could no longer continue stability testing, which may affect product safety.
The recall does not specify a stop-use instruction, but you should check with your healthcare provider for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0817-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0817-2023 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.
