← FDA ENFORCEMENT
D-0868-2026Class II

Amneal Pharmaceuticals of New York, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Ongoing
Report date
2026-09-30
Distribution
USA Nationwide
Firm state
NY
Product quantity
5,694 pens
Initiated by
Voluntary: Firm initiated
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

Code / lot info

Lot #: AP250095A, Exp 2/28/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →