Humalog KwikPen (Cardinal) – Temperature Abuse (2022)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59
Brand
Cardinal Health Inc.
Lot Codes / Batch Numbers
Unknown
Products Sold
Unknown
Cardinal Health Inc. is recalling Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, M due to TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NM
Page updated: Jan 7, 2026