EXENATIDE
Recalling Firm / Manufacturer: Amneal Pharmaceuticals of New York, LLC
(Brookhaven, NY, United States)
FDA Recall Number: D-0868-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
EXENATIDE
Generic Name
EXENATIDE
Active Substance(s)
Exenatide
Administration Route
Subcutaneous
National Drug Code (NDC)
70121-1685
Total Quantity Recalled
5,694 pens
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective Delivery System: Possibility of no medication in the prefilled pen.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 30, 2026
Firm Initiation Date
August 28, 2026
FDA Classification Date
Sep 22, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: AP250095A, Exp 2/28/2027
Distribution Information
Geographic scope of affected shipments
USA Nationwide
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0868-2026
Questo Retrieval Date: October 06, 2026 12:00 1791288015UTCC