Akorn Ropivacaine Injection Recall: Stability Issues After Manufacturer Closure

Take action

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 has recalled all 100mL ropivacaine hydrochloride injection vials because the manufacturer went out of business and can no longer perform stability testing. This means the product's safety and effectiveness cannot be guaranteed for medical use.

Why it’s dangerous

The manufacturer went out of business and can no longer conduct stability studies to ensure the product remains safe and effective over time. This creates uncertainty about the product's quality and safety for medical use.

Who’s affected

Prescription-only medical users who have the Akorn ropivacaine injection vials. Healthcare providers and patients using these vials for medical procedures are most at risk.

How to tell if you have this one

Check for Akorn, Inc. manufactured 100mL ropivacaine hydrochloride injection vials with NDC codes. All lots and all products are affected.

Brand
Akorn
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product is an Akorn 100mL ropivacaine injection vial with NDC codes.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The manufacturer went out of business and can no longer conduct stability studies to ensure the product remains safe and effective.

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 Akorn, Inc. manufactured 100mL ropivacaine hydrochloride injection vials with NDC codes.

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-0863-2023 — Akorn Akorn

Hello,

I own a Akorn that is covered by recall D-0863-2023 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0863-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0863-2023 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 Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn

Lower-risk recall