Akorn Fentanyl Injection Recall: Stability Studies Not Completed

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Recalling firmAkorn, Inc.5605 Centerpoint Ct Ste A, N/A · Gurnee, IL 60031-5278

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Akorn has recalled all Fentanyl Citrate Injection products because the manufacturer went out of business and could no longer complete stability testing. This means the product's safety and effectiveness cannot be guaranteed.

Why it’s dangerous

The manufacturer went out of business and could no longer conduct stability studies to ensure the product remains safe and effective over time. Without this testing, the medication's potency and safety cannot be confirmed.

Who’s affected

Prescription users of Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL) manufactured by Akorn Inc. in Lake Forest, IL are affected. Patients using this medication are at risk due to potential instability.

How to tell if you have this one

Check for the product name 'Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL)' and all NDCs and lots. This product was manufactured by Akorn Inc. in Lake Forest, IL.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name and NDCs to confirm if it is recalled.

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Questions people ask

Why was this product recalled?

The manufacturer went out of business and could no longer complete stability studies to ensure the product's safety and effectiveness.

Is there a remedy for this recall?

The recall record does not specify a remedy.

How can I tell if I have the recalled product?

Check for the product name 'Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL)' and all NDCs and lots manufactured by Akorn Inc. in Lake Forest, IL.

Take action

Contact Akorn

We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0843-2023 — Akorn Akorn

Hello,

I own a Akorn that is covered by recall D-0843-2023 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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Where this comes from

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.

Official source: FDA Recall #D-0843-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0843-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Akorn, Inc. recalls Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.

Recall notice