Exenatide Injection 250 mcg/mL Recall
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 Exenatide Injection 250 mcg/mL recalled?
Defective Delivery System: Possibility of no medication in the prefilled pen.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AP250095A, Exp 2/28/2027
- 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
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 5,694 pens
- Distribution
- USA Nationwide
- Recall started
- August 28, 2026
- Report date
- September 30, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)