Recall August 19, 2021

Trulicity (dulaglutide) Class II recall over label strength error

Eli Lilly and Company recalled a lot of Trulicity (dulaglutide) beginning August 19, 2021. The action, designated D-0773-2021, was classified as a Class II recall.

The recall affected Trulicity 0.75 mg/0.5 mL autoinjector pens, packaged four single-dose pens per box, NDC 0002-1433-80. According to the recall record, the reason was a labeling error involving declared strength. Pens labeled as 0.75 mg/0.5 mL were found to actually contain 1.5 mg/0.5 mL of product.

The recalling firm is Eli Lilly and Company, based in Indianapolis, Indiana. The recall status is listed as terminated. This classification and reason are reported as stated in the recall record, without additional interpretation of clinical impact.

Trulicity is an approved prescription product containing dulaglutide. This brief reports only the details included in the recall record: the classification, the stated reason, the recalling firm, and the initiation date. No further outcome or clinical data were provided in the event record beyond the terminated status.

For additional background on this compound, readers can consult the linked overview page.

See the full dulaglutide overview

Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts