Recall D-0868-2026

US Class II Ongoing · initiated 2026-08-28

Recalling firm

Amneal Pharmaceuticals of New York, LLC, NY

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.

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