Medications & Supplements/Prescription Drugs

Humalog and Trulicity Injections Recalled for Improper Temperature Storage

Agency Publication Date: May 20, 2022

Summary

Cardinal Health Inc. is recalling one box each of Humalog KwikPen (insulin lispro) and Trulicity (dulaglutide) injections because the products were exposed to temperatures outside of their required storage limits. The improper storage occurred during shipping due to inclement weather. No incidents or injuries have been reported to date. These prescription medications were distributed only in New Mexico.

Risk

Exposure to temperatures outside of labeled storage conditions can reduce the effectiveness of these diabetes medications. If the medication is not effective, patients may experience higher than expected blood sugar levels.

What You Should Do

This recall affects one box each of Humalog KwikPen (insulin lispro) and Trulicity (dulaglutide) injections distributed in New Mexico that were exposed to improper temperatures.
Check your Trulicity packaging for Lot D482749A (Exp 10/15/2023) with NDC 00002-1434-80, or Lot D484557A (Exp 10/25/2023) with NDC 0002-1433-80.
Check your Humalog KwikPen box for NDC 0002-8799-59 or the pen itself for NDC 002-7516-59. The lot number for the affected Humalog box is unknown.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Humalog KwikPen (Insulin lispro injection)

Variants: U-100, 100 units per mL, 5x3 mL Prefilled Pens per box

Lot Numbers:

Unknown

NDC:

0002-8799-59

002-7516-59

Recall #: D-0882-2022; Marketed by Lilly USA, LLC

Product: Trulicity (dulaglutide) injection 1.5 mg/0.5mL

Variants: 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens

Lot Numbers:

D482749A (Exp: 10/15/2023)

NDC:

00002-1434-80

Recall #: D-0883-2022; Eli Lilly and Company

Product: Trulicity (dulaglutide) injection 0.75 mg/0.5mL

Variants: 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens

Lot Numbers:

D484557A (Exp: 10/25/2023)

NDC:

0002-1433-80

Recall #: D-0884-2022; Eli Lilly and Company

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89976

Status: Resolved

Manufacturer: Cardinal Health Inc.

Sold By: Cardinal Health Inc.

Manufactured In: United States

Units Affected: 3 products (1 box)

Distributed To: New Mexico

Agency Last Updated: July 7, 2022

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 · 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

What You Should Do

This recall affects one box each of Humalog KwikPen (insulin lispro) and Trulicity (dulaglutide) injections distributed in New Mexico that were exposed to improper temperatures.

Check your Trulicity packaging for Lot D482749A (Exp 10/15/2023) with NDC 00002-1434-80, or Lot D484557A (Exp 10/25/2023) with NDC 0002-1433-80.

Check your Humalog KwikPen box for NDC 0002-8799-59 or the pen itself for NDC 002-7516-59. The lot number for the affected Humalog box is unknown.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Humalog KwikPen (Insulin lispro injection)

Variants: U-100, 100 units per mL, 5x3 mL Prefilled Pens per box

Lot Numbers:

Unknown

NDC:

0002-8799-59

002-7516-59

Recall #: D-0882-2022; Marketed by Lilly USA, LLC

Product: Trulicity (dulaglutide) injection 1.5 mg/0.5mL

Variants: 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens

Lot Numbers:

D482749A (Exp: 10/15/2023)

NDC:

00002-1434-80

Recall #: D-0883-2022; Eli Lilly and Company

Product: Trulicity (dulaglutide) injection 0.75 mg/0.5mL

Variants: 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens

Lot Numbers:

D484557A (Exp: 10/25/2023)

NDC:

0002-1433-80

Recall #: D-0884-2022; Eli Lilly and Company