Akorn recalls all hydromorphone injections due to company closure halting stability testing. This affects all lots and NDCs. Consumers should contact the manufacturer for details.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all hydromorphone hydrochloride injections because the company 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 went out of business and stopped stability testing, which is critical for ensuring the medication remains safe and effective over time. Without ongoing testing, the product could degrade, potentially leading to reduced effectiveness or safety issues.
Prescribers and patients who have received this medication from Akorn. Those using the product without proper stability testing are at risk of potential degradation.
Check for Akorn, Inc. branded hydromorphone hydrochloride injections in 1 mL, 5 mL, or 50 mL ampules or vials. All lots and National Drug Codes (NDCs) are affected.
Identify the product by checking the manufacturer, product name, and lot number on the packaging.
The manufacturer went out of business and could no longer continue stability studies, which are necessary to ensure the medication remains safe and effective.
Contact Akorn, Inc. for details on the product and next steps. The recall affects all lots and NDCs.
The recall does not specify a time frame for use; the product may degrade over time without ongoing stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0811-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0811-2023 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.
