FDA-Drug2026-09-30Class IIPROCESSING DEFECT
Amneal Exenatide Injection recalled for defective delivery system, empty pens
What this means
Some prefilled pens of Amneal Exenatide Injection may contain no medication due to a defective delivery system. This affects lot AP250095A (expiration 2/28/2027). Patients relying on these pens may not receive their intended dose.
- Check if your Exenatide Injection matches lot AP250095A (expiration 2/28/2027).
- Do not use the pen if you suspect it is defective or empty.
- Contact your pharmacy or doctor for a replacement or alternative diabetes medication.
- Report any problems with this medication to the FDA at 1-888-SAFEMEDS or online at fda.gov/medwatch.
The agency's original wording
Hazard
Defective Delivery System: Possibility of no medication in the prefilled pen.
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
5,694 pens
Manufactured in
50 Horseblock Rd, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0868-2026Want us to check the next one for you?
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