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, Bridgewate

FDA recall notice · announced September 30, 2026 · Amneal Pharmaceuticals Of New York

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: USA Nationwide
Lot/code information: Lot #: AP250095A, Exp 2/28/2027
Quantity: 5,694 pens
Status: Ongoing
Products in this recall event:
- 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; (D-0868-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.