Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use O
Summary
The FDA issued a Class II for Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcuta by Amneal Pharmaceuticals of New York, LLC. Reason: Defective Delivery System: Possibility of no medication in the prefilled pen..
Details
Source
Drug Recall
External ID
D-0868-2026
Action Date
2026-09-30
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: AP250095A, Exp 2/28/2027
Quantity Affected: 5,694 pens
Reason for Recall
Defective Delivery System: Possibility of no medication in the prefilled pen.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-28
Company
Brookhaven, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 26 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Amneal Pharmaceuticals of New York, LLC has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals of New York, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals of New York, LLC have FDA actions?
Amneal Pharmaceuticals of New York, LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0868-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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