Akorn recalls 300 mg/5mL Oxcarbazepine Oral Suspension bottles due to stability concerns after the manufacturer closed. All units are affected; no remedy specified.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 250mL bottles of Oxcarbazepine Oral Suspension (300 mg/5 mL) because the manufacturer went out of business and can no longer ensure the product's stability. This means the medication may not be safe to use as intended.
The manufacturer went out of business and stopped conducting stability studies, which means the product's safety and effectiveness cannot be confirmed. Without ongoing testing, the medication might degrade or become unsafe over time.
Prescription medication users who have the 250mL bottles of Oxcarbazepine Oral Suspension (300 mg/5 mL) from Akorn. Patients on seizure medication are most at risk if they use the product without proper stability testing.
Check for 250mL bottles labeled Oxcarbazepine Oral Suspension, 300 mg/5 mL, with the NDC code. All lots and all units are affected since the manufacturer closed.
Identify if you have the 250mL Oxcarbazepine Oral Suspension bottles with the specified strength and NDC codes.
The manufacturer went out of business and could no longer continue stability studies, so the product's safety and effectiveness cannot be confirmed.
The recall notice does not specify any remedy or action for consumers.
All 250mL bottles of Oxcarbazepine Oral Suspension (300 mg/5 mL) with NDC codes are affected, as the manufacturer closed and stopped stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0834-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0834-2023 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.
