Amneal Pharmaceuticals of New York, LLC recalls Exenatide Injection
- Recalling company
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 28, 2026
- Reported
- Sep 30, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 5,694 pens
- Lot / codes
- Lot #: AP250095A, Exp 2/28/2027
- Company location
- Brookhaven, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0868-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0868-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.