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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Eli Lilly & Company: Trulicity (dulaglutide) Recalled for Labeling Error on Drug Strength

Agency Publication Date: August 26, 2021
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Summary

Eli Lilly & Company has recalled 119,539 boxes of Trulicity (dulaglutide) 0.75 mg/0.5 mL because the autoinjector pens actually contain a higher dose of 1.5 mg/0.5 mL. This labeling error means patients may unknowingly inject double the intended amount of medication. This recall affects 4-pack boxes distributed nationwide across the United States. Consumers should check their pens immediately and contact their healthcare provider before using the medication.

Risk

Patients using these mislabeled pens will receive twice the prescribed dose of dulaglutide, which may cause severe gastrointestinal side effects such as nausea, vomiting, and abdominal pain, and could lead to more serious metabolic issues.

What You Should Do

  1. Check your Trulicity (dulaglutide) 4-pack box for NDC 0002-1433-80 and Lot number D396436C.
  2. Verify if your autoinjector devices are labeled as 0.75 mg / 0.5 mL, as these specific pens may actually contain 1.5 mg / 0.5 mL of medication.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have received the incorrect dose.
  4. Return any unused product from the affected lot to your pharmacy for a refund and contact Eli Lilly & Company for further instructions regarding replacement or disposal.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box
Model:
NDC 0002-1433-80
D-0773-2021
Lot Numbers:
D396436C

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88505
Status: Resolved
Manufacturer: Eli Lilly & Company
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 119,539 4-packs
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.