Akorn recalls 15 mg/5 mL prednisolone oral solution in 240mL and 480mL bottles due to stability concerns after the company went out of business. All lots and NDCs affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling prednisolone oral solution bottles (240mL and 480mL) because the company closed and can no longer test product stability. This means the medication may not be safe for long-term use.
The recall occurs because Akorn went out of business and stopped conducting stability studies. This means the medication's safety and effectiveness over time cannot be confirmed, though it may still be safe for short-term use.
Prescription patients who have received this specific prednisolone oral solution from Akorn. Those with ongoing medical treatment using this medication are most at risk.
Check for prednisolone oral solution bottles labeled 15 mg/5 mL, available in 240mL or 480mL sizes. All lots and National Drug Codes (NDCs) are affected.
Identify the product by checking the label for 15 mg/5 mL prednisolone oral solution in 240mL or 480mL bottles.
The company went out of business and can no longer perform stability studies to ensure the medication remains safe and effective over time.
The recall is due to stability concerns after the company closed, but the medication may still be safe for short-term use. Consult your doctor for guidance.
Check the label to confirm the product details. If you have it, contact your doctor or pharmacist for advice on safe use or alternatives.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0836-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0836-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
