Why it was recalled
Defective Delivery System: Possibility of no medication in the prefilled pen.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: AP250095A, Exp 2/28/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0868-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 28, 2026
- FDA report date
- Sep 30, 2026
- Quantity
- 5,694 pens
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0868-2026, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99762
- Address
- 50 Horseblock Rd
- Code information
- Lot #: AP250095A, Exp 2/28/2027
- Postal code
- 11719-9509
- Report date
- Sep 30, 2026
- Product type
- Drugs
- Recall number
- D-0868-2026
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 5,694 pens
- Reason for recall
- Defective Delivery System: Possibility of no medication in the prefilled pen.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 28, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2026