Mislabeling of Drug Autoinjector Prompts Recall

A labeling error has prompted Eli Lilly & Company to recall a single lot of Trulicity (dulaglutide). According to the September 1, 2021, US Food and Drug Administration (FDA) Enforcement Report, autoinjector devices labeled as 0.75 mg/0.5 mL actually contain 1.5 mg/0.5 mL of product.

The recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C. The FDA Enforcement Report did not include the lot’s expiration date or where the products were manufactured. The medication was distributed throughout the United States.  

Eli Lilly & Company initiated the voluntary recall August 19, 2021. On August 26, 2021, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Trulicity is a prescription medication used to help control high blood sugar in people with type 2 diabetes.