Amneal Pharmaceuticals of New York, LLC initiated a recall of Exenatide Injection, USP, 250 mcg/mL, on August 28, 2026. The recall is classified as Class II by the FDA.
The recalled product is a prefilled pen containing 1.2 mL, intended for subcutaneous use by a single patient. It is manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India, and distributed by Amneal Pharmaceuticals LLC of Bridgewater, New Jersey, under NDC 70121-1685-1.
The stated reason for the recall is a defective delivery system, which creates the possibility that a prefilled pen may contain no medication. The recall status is listed as ongoing.
This recall action reflects a specific device defect reported for this lot or product line, as described in the FDA recall data. No additional details about the scope of affected units or further corrective steps are included in this record.
Readers seeking general background on exenatide, including its approved uses and regulatory status, can consult the compound overview for further context.