Quick answers
- What is Dulaglutide used for?
- The FDA-approved label (Trulicity, Eli Lilly and Company, June 16, 2026) says: “TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dulaglutide have a boxed warning?
- Yes. The FDA label for Trulicity has a boxed warning (“WARNING: RISK OF THYROID C-CELL TUMORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dulaglutide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dulaglutide been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 5, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dulaglutide?
- 2 companies list prescription products of Dulaglutide in the FDA NDC Directory, including A-S Medication Solutions and Eli Lilly and Company.
What Dulaglutide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple …
— FDA label: Trulicity, Eli Lilly and Company, effective June 16, 2026. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF THYROID C-CELL TUMORS
. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Trulicity |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dulaglutide 0.75 mg/0.5 mL injection, solution | Brand: Trulicity | $487.65 per mL |
| dulaglutide 1.5 mg/0.5 mL injection, solution | Brand: Trulicity | $487.62 per mL |
| dulaglutide 3 mg/0.5 mL injection, solution | Brand: Trulicity | $487.56 per mL |
| dulaglutide 4.5 mg/0.5 mL injection, solution | Brand: Trulicity | $487.42 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions7 products
- Eli Lilly and Company4 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125469 TRULICITY | Eli Lilly and Co | September 18, 2014 | 21, latest March 12, 2026 2026: Labeling · 2025: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 5, 2022 · Class II · Completed · D-0884-2022
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 — Cardinal Health Inc.
-
August 19, 2021 · Class II · Terminated · D-0773-2021
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 — Eli Lilly & Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trulicity, Eli Lilly and Company, effective June 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →