FDA Drugs recall ·

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only… recall

Recall number
D-0868-2026
Date
(initiated August 28, 2026)
Company / brand
Amneal Pharmaceuticals of New York, LLC
50 Horseblock Rd, Brookhaven, NY, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
5,694 pens
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: AP250095A, Exp 2/28/2027

Distribution

USA Nationwide

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0868-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.