Akorn recalls 250mg/5mL Valproic Acid Oral Solution bottles due to stability concerns after manufacturer went out of business. All units are affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 250mg/5m: 473 mL bottles of Valproic Acid Oral Solution 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 stability testing, meaning the product's effectiveness and safety could degrade over time. This is a regulatory issue, not an immediate hazard like a fire or breakage.
Prescription patients who own the recalled Valproic Acid Oral Solution bottles. Those with seizure disorders or other conditions requiring this medication are at risk if the product becomes unstable.
Check for 250mg/5mL Valproic Acid Oral Solution bottles labeled with NDC numbers. All lots and all units are affected, so no specific model or date range applies.
Identify the product by checking the NDC number and lot number on the bottle.
The recall states the manufacturer can no longer ensure stability, so the product may not be safe. Consult a healthcare provider for advice.
All 250mg/5mL Valproic Acid Oral Solution bottles with NDC numbers are affected, as the manufacturer went out of business and stopped stability testing.
The recall does not specify a remedy, so contact your healthcare provider 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-0854-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0854-2023 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.
