Amneal Exenatide Injection
Exenatide Injection prefilled pens may contain no medication due to a defective delivery system.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Amneal Pharmaceuticals of New York, LLC, of Brookhaven, New York, recalled Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, because of a defective delivery system that may result in no medication in the prefilled pen. The product, manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India, and distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, was distributed nationwide in the USA.
The recall began on August 28, 2026, and was added to the FDA's Enforcement Report on September 22, 2026. The FDA classified the recall on September 22, 2026, and it was in the FDA's weekly enforcement report on September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen
- NDC
- 70121-1685-1
- Lot
- AP250095A
Details
- Company began the recall
- Sold in
USA Nationwide
- Event ID
- 99762
- Recall No.
- D-0868-2026
- Company
- Amneal Pharmaceuticals of New York, LLCBrookhaven, New York
- Quantity recalled
- 5,694 pens
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
