Akorn recalls all Albuterol Sulfate Syrup bottles due to stability concerns after the manufacturer ceased operations. This affects prescription-only products distributed by Akorn Operating Company.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all prescription Albuterol Sulfate Syrup bottles because the manufacturer went out of business and can no longer ensure the product's stability. This means the syrup may not be safe for use after the recall date.
The manufacturer went out of business and stopped stability testing, meaning the product's safety and effectiveness could be compromised over time. This is a regulatory issue, not an immediate hazard like a fire or injury.
Prescription holders of Albuterol Sulfate Syrup (2mg base, 16 fl oz) distributed by Akorn Operating Company. Those with the product are most at risk if they use it without checking stability.
Check for bottles labeled 'Albuterol Sulfate Syrup, 2mg (base), 1:16 fl oz (473 mL) per bottle' with prescription-only status. All National Drug Codes (NDCs) and all production lots are affected.
Look for the product name and dosage on the bottle label to confirm it matches the recalled items.
Ask your pharmacist if you have the recalled product and whether they can provide a safe alternative.
The recall states the manufacturer can no longer ensure stability, so it may not be safe for long-term use. Consult your pharmacist for advice.
All bottles with the product name 'Albuterol Sulfate Syrup, 2mg (base), 16 fl oz' and prescription-only status are affected.
Contact your pharmacist for guidance on safe alternatives or disposal.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0783-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0783-2023 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.
