Class IIDrug
Exenatide Injection recall
Summary
Amneal Pharmaceuticals of New York, LLC is recalling Exenatide Injection (drug). According to the FDA report, the reason is: Defective Delivery System: Possibility of no medication in the prefilled pen. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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.
- Lot / code info
- Lot #: AP250095A, Exp 2/28/2027
- Quantity
- 5,694 pens
- Distribution
- USA Nationwide
- Recalling company
- Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY United States
- Recall started
- August 28, 2026
- FDA report date
- September 30, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0868-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Amneal Pharmaceuticals of New York, LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.