The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0882-2022·Announced 2022-05-25

Insulin lispro pens recalled for temperature exposure during distribution

Cardinal Health is recalling Humalog KwikPen insulin lispro pens distributed in New Mexico due to exposure to improper temperatures caused by inclement weather.

The agency’s classification

FDA (Drugs): Class I

Class I is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. The severity rubric specifies that FDA Class I recalls receive a minimum score of 4, indicating a serious condition with potential for adverse health consequences.

Plain-English summary

Cardinal Health Inc. is recalling Humalog KwikPen insulin lispro injection, U-100, in prefilled pens with Box NDC 0002-8799-59. The recall affects pens distributed in New Mexico.

According to the recall notice, the products were exposed to temperatures outside their labeled storage conditions due to inclement weather during distribution.

Patients who have received affected pens should contact their healthcare provider to determine if the product should be used, and may contact Cardinal Health for further information regarding the recall.

The recalled product

Product
HUMALOG (INSULIN LISPRO)
Brand
HUMALOG
Manufacturer
Cardinal Health Inc.
Category
Drug — Insulin / Injectable
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Unknown

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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