August 2026 FDA Recall Exenatide by Amneal Pharmaceuticals Of New York, Llc
D-0868-2026 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on August 28, 2026 for the product Exenatide. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0868-2026
Defective Delivery System: Possibility of no medication in the prefilled pen.
08-28-2026
09-30-2026
5,694 pens
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : AP250095A, Exp 2/28/2027
