Recall: D-0868-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-28Initiated

OngoingStatus

Amneal Pharmaceuticals of New Firm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.