Trulicity autoinjector pens recalled for incorrect strength labeling
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a significant dosing error (100% overdose). Incorrect drug dosing poses a substantial risk of adverse health consequences, including potential hospitalization. The hazard is not theoretical—patients receiving double the prescribed dose face real clinical risk.
Plain-English summary
Eli Lilly & Company is recalling Trulicity (dulaglutide) autoinjector pens due to a labeling error. The pens are labeled as containing 0.75 mg / 0.5 mL, but actually contain 1.5 mg / 0.5 mL of product—double the declared strength.
The affected product is Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box (NDC 0002-1433-80), lot number D396436C. Approximately 119,539 4-packs were distributed nationwide in the USA.
Patients using these pens may administer a higher dose than prescribed, which could result in unintended health effects. Trulicity is a prescription medication used to treat type 2 diabetes. Consumers who have this lot should contact their healthcare provider or pharmacist immediately for guidance. Patients should not stop taking their diabetes medication without consulting their doctor.
The recalled product
- Product
- TRULICITY (DULAGLUTIDE)
- Brand
- TRULICITY
- Manufacturer
- Eli Lilly & Company
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: D396436C
Distribution
Distributed nationwide across the United States.
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