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Class II · ModerateActive recall

Exenatide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AP250095A, Exp 2/28/2027
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Brand nameEXENATIDE
Generic nameEXENATIDE
Active ingredient(s)EXENATIDE
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC70121-1685-1
Show the full FDA record
Full product labelExenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionUSA Nationwide
Quantity5,694 pens
Recall initiated2026-08-28
Report date2026-09-30
Recall completed—
Recall numberD-0868-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBrookhaven NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.