Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use…

Amneal Pharmaceuticals of New York, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Is this the product you have?

  • Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only
  • Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India
  • Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
Lot codes and dates
    • Lot #: AP250095A
    • Exp 2/28/2027
Amount recalled
5,694 pens

Where it was sold

  • Nationwide

Why it was recalled

Defective Delivery System: Possibility of no medication in the prefilled pen.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Nov 4, 1:05 AM UTC

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