Akorn recalls all Levofloxacin Injection 500mg/20mL vials due to stability concerns after the manufacturer closed and could no longer conduct required testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all Levofloxacin Injection 500mg/20mL vials because the manufacturer went out of business and can no longer perform stability tests. This means the product may not be safe for use as it could degrade over time.
The manufacturer closed and stopped stability testing, which means the product's safety and effectiveness over time cannot be confirmed. Without ongoing testing, the medication might degrade or become ineffective.
Prescription patients who received this medication from a pharmacy or healthcare provider. Those most at risk are individuals using the product for serious infections who need consistent treatment.
Check for vials labeled 'Levofloxacin Injection 500mg/20 mL (25 mg/mL)' in 20mL or 30mL sizes. All products were manufactured by Akorn, Inc. in Lake Forest, IL and have all NDC numbers and lots.
Identify the vial size and label to confirm if it matches the recalled product.
Ask your pharmacy about the product and whether they can provide an alternative or replacement.
The manufacturer went out of business and could no longer continue stability studies, which are required to ensure the product remains safe and effective over time.
The recall applies to all products manufactured by Akorn, Inc., but there is no specific expiration date for the product as stability testing has stopped.
Check with your pharmacist for alternatives or guidance on safe disposal if you no longer need the medication.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0818-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0818-2023 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.
