Exenatide Injection recall (Amneal Pharmaceuticals of New York, LLC)
DrugClass IIOngoing
Summary: Amneal Pharmaceuticals of New York, LLC is recalling 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. Reason: Defective Delivery System: Possibility of no medication in the prefilled pen.
What is being recalled
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
Defective Delivery System: Possibility of no medication in the prefilled pen.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: AP250095A, Exp 2/28/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0868-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 28, 2026 |
| Reported | September 30, 2026 |
| Company | Amneal Pharmaceuticals of New York, LLC |
| Company location | Brookhaven, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5,694 pens |
More recalls from Amneal Pharmaceuticals of New York, LLC · all drug recalls · recalls from August 2026