FDAFDA · Food and drugs·Recall number D-0868-2026
Exenatide 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
Published September 30, 2026 · Recall initiated: August 28, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: Possibility of no medication in the prefilled pen.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EXENATIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- USA Nationwide
- Lot
- Lot #: AP250095A, Exp 2/28/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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Questions about this recall
Was Exenatide 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 recalled?
Yes. FDA published recall D-0868-2026 on September 30, 2026. Reported hazard: Defective Delivery System: Possibility of no medication in the prefilled pen.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: EXENATIDE.
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