FDA Drug recall D-0882-2022
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis…
- FDA Drug
- Class I
- completed
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class I recall of Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis… by Cardinal Health, citing TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0882-2022 |
| Classification | Class I |
| Status | completed |
| Initiated | 2022-04-05 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | NM |
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
Reason
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Identifiers
| ndc | 0002-7510-01 |
|---|---|
| ndc | 0002-7510-17 |
| ndc | 0002-7533-01 |
| ndc | 0002-8799-01 |
| ndc | 0002-8799-59 |
| ndc | 0002-7516-01 |
| ndc | 0002-7516-59 |
| ndc | 0002-7516-99 |
| ndc | 0002-7714-01 |
| ndc | 0002-7714-59 |
| ndc | 0002-7714-61 |
| ndc | 0002-8213-01 |
| ndc | 0002-8213-05 |
| ndc | 0002-0800-01 |
| ndc | 0002-7712-01 |
| ndc | 0002-7712-27 |
| ndc | 0002-7712-61 |
| code_info | Unknown |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class II · 2025-09-03 · Cardinal Health - RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
FDA Drug · Class II · 2025-08-13 · Cardinal Health - Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55
FDA Drug · Class II · 2025-08-13 · Cardinal Health - Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
FDA Drug · Class II · 2025-08-13 · Cardinal Health - Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose On…
FDA Drug · Class II · 2025-05-07 · Cardinal Health
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0882-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.