Akorn DetomiSed 5mL/20mL Vials: CGMP Deviations Risk

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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 is recalling all 5mL and 20mL DetomiSed vials (Rx only) because the manufacturer went out of business and could no longer complete stability studies. This means the product may not be safe for use as it was not properly tested.

Why it’s dangerous

The manufacturer went out of business and could no longer complete stability studies. This means the product's safety and effectiveness could not be confirmed, potentially leading to adverse effects if used.

Who’s affected

Prescribers and patients who have received DetomiSed vials from Akorn. Those using the product for veterinary or medical purposes are at risk.

How to tell if you have this one

Check for DetomiSed vials labeled 5mL or 20mL, Rx only, distributed by Akorn Operating Company, LLC. All lots and all NDCs are affected.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Discard all DetomiSed vials (5mL and 20mL) as they are no longer safe due to CGMP deviations.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The manufacturer went out of business and could no longer complete stability studies, so the product's safety and effectiveness could not be confirmed.

How can I tell if I have the recalled product?

Check for DetomiSed vials labeled 5mL or 20mL, Rx only, distributed by Akorn Operating Company, LLC. All lots and all NDCs are affected.

What should I do with the product?

Discard all DetomiSed vials (5mL and 20mL) as they are no longer safe due to CGMP deviations.

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-0798-2023 — Akorn Akorn

Hello,

I own a Akorn that is covered by recall D-0798-2023 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-0798-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0798-2023 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 DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating

Recall notice