Exenatide Injection recall
FDA recall D-0868-2026 · initiated Aug 28, 2026
Amneal Pharmaceuticals of New York, LLC recalled Exenatide Injection in Aug 2026 — an FDA Class II recall (D-0868-2026) because Defective Delivery System: Possibility of no medication in the prefilled pen.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Delivery System: Possibility of no medication in the prefilled pen.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,694 pens
Details
- 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
- Recalling company
- Amneal Pharmaceuticals of New York, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Aug 28, 2026
- FDA report date
- Sep 30, 2026
Frequently asked
- Was Exenatide Injection recalled?
- Amneal Pharmaceuticals of New York, LLC recalled Exenatide Injection in Aug 2026 — an FDA Class II recall (D-0868-2026) because Defective Delivery System: Possibility of no medication in the prefilled pen. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Exenatide Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0868-2026 was: Defective Delivery System: Possibility of no medication in the prefilled pen.
- Is a recalled Exenatide Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Exenatide Injection are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: AP250095A, Exp 2/28/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0868-2026.