CLASS I Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Humalog KwikPen, Insulin lispro injection, U-100 per mL recalled
Cardinal Health is recalling Humalog KwikPen, Insulin lispro injection, U-100 per mL, mL Prefilled Pens per, distributed in New Mexico. The recall was initiated on 5 Apr 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0882-2022
- FDA event ID
- 89976
- Recalling firm
- Cardinal Health, Dublin, OH
- Brand
- Humalog
- Manufacturer
- Eli Lilly and Company
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 5 Apr 2022
- FDA classified
- 19 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Diabetes Medication
Timeline
| 5 Apr 2022 | Recall initiated by company | |
| 19 May 2022 | Classified by FDA | +44 days |
| 25 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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
Where it was distributed
NM only
Questions about this recall
Why was it recalled?
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Which lots are affected?
Unknown
Where was it sold?
NM only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89976This product is part of a recall event; the main page for the event is Trulicity (dulaglutide) injection, 0.75 mg/ once weekly-Dose Pens recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Trulicity (dulaglutide) injection, 0.75 mg/ once weekly-Dose Pens recalledTrulicity | Cardinal Health | Temperature Abuse | NM | |
| CLASS II | Trulicity (dulaglutide) injection, 1.5 mg/ once weekly-Dose Pens recalled | Cardinal Health | Temperature Abuse | NM |
More recalls from Cardinal Health
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
Other Insulin Lispro recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Diluent, Humalog U-100 (insulin lispro injection) recalledHumalog | Eli Lilly | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS II | Admelog Solostar (insulin lispro injection)/ mL (U-100) injection recalledAdmelog | Sanofi-Aventis U.S | Temperature Abuse | Nationwide |