FDA Drug · D-0868-2026

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

Class II · Ongoing

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

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Affected lots / codes — check yours against thisLot #: AP250095A, Exp 2/28/2027
Recalling firm
Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
5,694 pens
Distribution
USA Nationwide
Recall initiated
August 28, 2026
Classified
September 22, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0868-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →