FDA recall D-0868-2026

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.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2026-08-28

Report date

2026-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2026