Class II

Drug Recall: 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;

Amneal Pharmaceuticals of New York, LLC · August 28, 2026

Reason for Recall

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

Product Description

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

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

5,694 pens

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0868-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.