Exenatide Recall: Amneal NDC 70121-1685-1
Announced 2026-09-30 · FDA
FDA recalls Exenatide Injection pens due to a defective delivery system that may deliver no medication. About 5,694 pens were distributed nationwide in the USA; the affected lot is AP250095A, exp 02/28/2027, manufactured by Amneal Pharmaceuticals Pvt. Ltd. and distributed by Amneal Pharmaceuticals LLC.
| Brand | Amneal Pharmaceuticals of New York, LLC |
|---|---|
| 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 |
| Reason | Defective Delivery System: Possibility of no medication in the prefilled pen. |
| Severity | moderate |
| Units affected | 5694 |
| Distribution | USA Nationwide |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use pens from lot AP250095A.
- Contact your prescriber or pharmacist for replacement options.
- If you have a recalled pen, set it aside and follow disposal guidance from your healthcare provider or local regulations.
How to identify the recalled item
| Lot / date codes | Lot #: AP250095A, Exp 2/28/2027 |
|---|---|
| Lot / date codes | Lot #: AP250095A, Exp 2/28/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.