Medications & Supplements/Prescription Drugs

Eli Lilly & Company: Glucagon Emergency Kit Recalled for Lack of Efficacy and Subpotency

Agency Publication Date: October 14, 2021

Summary

Eli Lilly & Company is recalling 19,174 units of its Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg). The recall was initiated because some vials contained a liquid substance instead of the expected powder, resulting in the medication being subpotent and failing to provide a full drug effect. Consumers rely on this kit for the emergency treatment of severe hypoglycemia, and a lack of efficacy can lead to serious health complications.

Risk

The drug is intended for emergency use during life-threatening low blood sugar events; if the medication is subpotent or ineffective, the patient may not recover from hypoglycemia, which can lead to seizures, loss of consciousness, or death. Reports have indicated a lack of full drug effect upon administration in the affected lots.

What You Should Do

Check your Glucagon Emergency Kit for Low Blood Sugar (1 mg per vial) to see if it belongs to Lot #: D239382D with an expiration date of April 2022.
Inspect the vial inside the kit; if you see a liquid substance instead of the expected white powder, do not attempt to use it as it will not provide the necessary medical effect.
Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement kit if you have an affected product.
Return any unused, affected product from Lot #: D239382D to your pharmacy for a refund and contact Eli Lilly & Company for further instructions at 1-800-LILLY-RX (1-800-545-5979).
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund and guidance for subpotent drug

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

Affected Products

Product: Glucagon Emergency Kit for Low Blood Sugar (1 mg per vial)

Model:

NDC: 0002-8031-01

Lot Numbers:

D239382D (Exp. Date April 2022)

Date Ranges: Expiration Date April 2022

Product Images

Glucagon Emergency Kit for Low Blood Sugar, front of packaging

Glucagon Emergency Kit for Low Blood Sugar, back of packaging

Glucagon for injection, 1 mg per vial

Glucagon for injection, lot number and lot code

Glucagon Emergency Kit, inside of packaging

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88764

Status: Resolved

Manufacturer: Eli Lilly & Company

Sold By: Lilly USA, LLC; pharmacies

Manufactured In: United States

Units Affected: 19,174 syringes

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 · FDA Press Release · 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.

Summary

Risk

What You Should Do

Check your Glucagon Emergency Kit for Low Blood Sugar (1 mg per vial) to see if it belongs to Lot #: D239382D with an expiration date of April 2022.

Inspect the vial inside the kit; if you see a liquid substance instead of the expected white powder, do not attempt to use it as it will not provide the necessary medical effect.

Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement kit if you have an affected product.

Return any unused, affected product from Lot #: D239382D to your pharmacy for a refund and contact Eli Lilly & Company for further instructions at 1-800-LILLY-RX (1-800-545-5979).

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.