FDA Drug recall D-0616-2021
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample
- FDA Drug
- Class I
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class I recall of NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample by Novo Nordisk, citing temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0616-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novo Nordisk |
| Distribution | US |
Product
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90
Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Identifiers
| ndc | 0169-7501-11 |
|---|---|
| ndc | 0169-7501-90 |
| ndc | 0169-3303-12 |
| ndc | 0169-3303-91 |
| ndc | 0169-3303-90 |
| ndc | 0169-6339-10 |
| ndc | 0169-6339-90 |
| ndc | 0169-6339-97 |
| ndc | 0169-6339-98 |
| ndc | 0169-6338-10 |
| ndc | 0169-6338-90 |
| ndc | 0169-6338-97 |
| ndc | 0169-2001-90 |
| ndc | 0169-2100-11 |
| ndc | 0169-2101-12 |
| ndc | 0169-2101-25 |
| code_info | JZFC826 exp 06/30/2021; KZFM305 exp 08/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0616-2021%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.