Akorn Acetic Acid Otic Solution Recall: CGMP Deviations Due to Company Closure

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Akorn is recalling all 15mL Acetic Acid Otic Solution bottles (prescription-only) because the company went out of business and can no longer ensure the product's safety through stability testing. This means the product may not be safe for use as intended.

Why it’s dangerous

The company 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 product's safety cannot be guaranteed.

Who’s affected

Prescription patients who have been prescribed Acetic Acid Otic Solution. Those with the product are most at risk due to the company's closure.

How to tell if you have this one

All 15mL Acetic Acid Otic Solution bottles (prescription-only) distributed by Akorn Operating Company LLC. The product has no specific lot or NDC numbers listed in the recall notice.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product name and prescription label to confirm it's the recalled Acetic Acid Otic Solution.

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Questions people ask

Why is this product being recalled?

The company went out of business and could no longer continue stability studies to ensure the product's safety.

Is there a remedy for this recall?

The official notice does not provide any remedy steps.

How can I tell if I have the recalled product?

All 15mL Acetic Acid Otic Solution bottles (prescription-only) distributed by Akorn Operating Company LLC are affected.

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-0781-2023 — Akorn Akorn

Hello,

I own a Akorn that is covered by recall D-0781-2023 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-0781-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0781-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031.

Recall notice