Akorn recalls Megestrol Acetate Oral Suspension 40 mg/mL 240mL bottles due to stability concerns after manufacturer went out of business. All units affected.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling Megestrol Acet:ate Oral Suspension bottles because the manufacturer went out of business and can no longer ensure the product remains stable. This means the medication may not be safe to use as intended.
The manufacturer went out of business and can no longer conduct stability testing. This means the product's safety and effectiveness cannot be guaranteed over time, though it does not indicate immediate harm.
Patients prescribed Megestrol Acetate by a doctor who received this specific product from Akorn. Those using the medication without medical supervision are not affected.
Check for Megestrol Acetate Oral Suspension 40 mg/mL, 240 mL bottles labeled with NDC numbers. All lots and all distribution channels are affected.
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 it may not be safe. Consult your doctor before using.
The recall does not specify a return process, so contact your pharmacy or doctor for guidance.
The product may not be safe due to stability issues, but the recall does not indicate immediate harm.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0827-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0827-2023 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.
