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Drug recall · FDA · Published August 28, 2026

Amneal Pharmaceuticals of New York, LLC recalls Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use

Amneal recalls Exenatide injection pens that may contain no medication. This could lead to ineffective diabetes treatment. Check your pen's lot number and contact Amneal for details.

🇺🇸 FDA recall #D-0868-2026DrugAmneal ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Amneal is recalling Exenatide injection pens that might not contain medication. This could cause ineffective diabetes treatment if the pen is used without the proper dose. Read more at govinfonow.com/recall/1287572-amneal-exenatide-injection-recall-risk-of-no-medication-in-prefilled.

Source Summary by GovInfoNow · govinfonow.com/recall/1287572-amneal-exenatide-injection-recall-risk-of-no-medication-in-prefilled · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #D-0868-2026

Cite this page

“Amneal Exenatide Injection Recall: Risk of No Medication in Prefilled Pen.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1287572-amneal-exenatide-injection-recall-risk-of-no-medication-in-prefilled. Based on FDA recall #D-0868-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2026%22&limit=1).

Why it’s dangerous

The prefilled pen may not contain the correct medication dose. This could result in the patient not receiving the intended diabetes treatment. The issue is with the delivery system, not the medication itself.

Who’s affected

People with diabetes who use this specific Exenatide injection pen for treatment. Those who have the pen with lot number AP250095A are most at risk.

How to tell if you have this one

Check for the lot number AP250095A on the pen. The product was manufactured in India and distributed by Amneal Pharmaceuticals LLC in New Jersey.

  • Brand
    Amneal
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Pen Lot Number

    Look for the lot number AP250095A on the prefilled pen.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a possible issue with the delivery system, but the product is not safe if it may contain no medication.

How do I know if I have the recalled product?

Check the lot number on the pen; the recalled product has lot number AP250095A.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact Amneal Pharmaceuticals for further instructions.

Take action

Contact Amneal

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

Subject: Recall D-0868-2026 — Amneal Amneal

Hello,

I own a Amneal that is covered by recall D-0868-2026 from Amneal.

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-0868-2026 (August 28, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0868-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA