Exenatide Injection
FDA Recall NDC 70121-1685
Latest: Class II · Status: Ongoing · Initiated Aug 28, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Exenatide (NDC 70121-1685). A significant event, classified as Class II, was initiated on Aug 28, 2026 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Defective Delivery System: Possibility of no medication in the prefilled pen."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective Delivery System: Possibility of no medication in the prefilled pen.
Aug 28, 2026
Sep 30, 2026
5,694 pens
Recall Profile & Regulatory Data
Event ID
99762
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
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
Batch or Lot Expiration Information
Lot# : AP250095A, Exp 2/28/2027
Affected Packages Involved in this Recall
70121-1685-1Exenatide
70121-1686-1Exenatide
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
