Exenatide Injection Recalled Due to Defective Delivery System
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for exenatide injection, USP, 250 mcg/mL. The affected batch has been identified as Lot AP250095A (expires February 2027), containing 5694 pens.
- The recall was initiated by Amneal Pharmaceuticals, LLC due to a defective drug delivery system, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Exenatide is used to treat type 2 diabetes.
The FDA has issued a Class II recall for exenatide injection, USP, 250 mcg/mL, affecting 5694 pens. This product is being recalled by Amneal Pharmaceuticals, LLC based in Brookhaven, New York. The recall was initiated on August 28, 2026, and received a Class II classification on September 22, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated after the firm realized the pens may not have been filled with medication. This deficiency affects Lot AP250095A, which will expire in February 2027. Amneal Pharmaceuticals sent out a public notice via letter; no press release was issued for this recall.
Exenatide is used in combination with diet and exercise to treat type 2 diabetes. Pharmacists should identify and quarantine Lot AP250095A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. September 30, 2026. Accessed September 30, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222427
