Lower risk Drug recall · FDA · Published August 19, 2021

Eli Lilly Trulicity 0.75mg Pens Contain 1.5mg Due to Label Error

Eli Lilly recalls Trulicity pens labeled 0.75mg but containing 1.5mg due to labeling error. Patients may receive higher dose than intended.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0773-2021Drug Eli Lilly ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmEli Lilly & Company839 S Delaware St · Indianapolis, IN 46225-1782

✎ GovInfoNow plain-language explainer

Eli Lilly is recalling Trulicity pens that are labeled as 0.75 mg per pen but actually contain 1.5 mg. This labeling error means patients could receive a higher dose than intended, potentially leading to adverse effects. Read more at govinfonow.com/recall/35929-eli-lilly-trulicity-0-75mg-pens-contain-1-5mg-due.

Source Summary by GovInfoNow · govinfonow.com/recall/35929-eli-lilly-trulicity-0-75mg-pens-contain-1-5mg-due · Updated August 18, 2026 · FDA enforcement record: FDA #D-0773-2021

Cite this page

“Eli Lilly Trulicity 0.75mg Pens Contain 1.5mg Due to Label Error.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35929-eli-lilly-trulicity-0-75mg-pens-contain-1-5mg-due. Based on FDA recall #D-0773-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2021%22&limit=1).

Eli Lilly & Company voluntarily recalled Trulicity (dulaglutide) autoinjectors due to a labeling error that caused devices labeled as 0.75 mg/0.5 mL to contain 1.5 mg/0.5 mL, the Food and Drug Administration said on Aug. 19, 2021.

How to tell if you have it

Brand: Eli Lilly
Product: Trulicity (dulaglutide)
Strength: 0.75 mg/0.5 mL
Packaging: 4 Single-Dose Pens per box
NDC: 0002-1433-80
Lot number: D396436C

The hazard

The recall involves a labeling error where autoinjector devices declared as containing 0.75 mg/0.5 mL of product actually contained 1.5 mg/0.5 mL.

Context

GovInfoNow's records show Eli Lilly & Company has 3 other recalls on record since June 29, 2021. Other recent recalls of similar products include Safecor Atomoxetine Capsules 10mg Mislabeled as 25mg (April 30, 2026), Alvogen Thyro-Tabs 150mcg Tablets Recall (Dec. 31, 2025), and Slate Run Recalls Eptifibatide Injection (Feb. 12, 2026).

How to tell if you have this one

Check if your Trulicity pens are labeled as 0.75 mg per pen (dulaglutide) but contain 1.5 mg of product. The product is sold by Eli Lilly and has NDC 0002-1433-80.

Brand
Eli Lilly
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Pen Label
Verify the label on the pen states 0.75 mg per dose but contains 1.5 mg of product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Aug 19, 2021Firm started the recall
Aug 26, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report
Aug 7, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35929-eli-lilly-trulicity-0-75mg-pens-contain-1-5mg-due">Eli Lilly Trulicity 0.75mg Pens Contain 1.5mg Due to Label Error (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0773-2021 (August 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0773-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.