Akorn recalls all DOCU LIQUID (docusate sodium) bottles and cups due to stability concerns after the manufacturer ceased operations. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all DOCU LI: 50 mg/5 mL docusate sodium liquid in 473mL bottles and 10mL unit dose cups because the manufacturer went out of business and can no longer conduct stability testing. This means the product may not be safe for use as the manufacturer no longer has the capability to ensure its quality.
The manufacturer went out of business and can no longer perform stability studies, which are necessary to ensure the product remains safe and effective over time. Without these studies, there's a risk the medication could degrade or become unsafe for consumption.
All owners of DOCU LIQUID (docusate sodium) in 473mL bottles and 10mL unit dose cups distributed by Akorn are affected. People using this product for bowel regularity may be at risk if the product has degraded due to lack of stability testing.
Check for DOCU LIQUID (docusate sodium, 50 mg/5 mL) in 473mL bottles or 10mL unit dose cups. All lots and all National Drug Codes (NDCs) are included in this recall.
Identify if your product matches the description: DOCU LIQUID (docusate sodium, 50 mg/5 mL) in 473mL bottles or 10mL unit dose cups.
The manufacturer went out of business and can no longer continue stability studies, which are necessary to ensure the product remains safe and effective over time.
The official recall notice does not provide a specific remedy, so no action is required beyond checking if your product is affected.
The recall notice does not specify a deadline for action.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0801-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0801-2023 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.
