FDAFDA recall D-0868-2026 · Sep 30, 2026
Amneal Pharmaceuticals of New York, LLC: Exenatide Injection recall
Recall found
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 for recall
Defective Delivery System: Possibility of no medication in the prefilled pen.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: AP250095A, Exp 2/28/2027
- Quantity
- 5,694 pens
- Distribution
- USA Nationwide
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-28
Source: openFDA enforcement record D-0868-2026 · search recall number D-0868-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.