TRESIBA FlexTouch — Class I drug recall D-0621-2021
Terminated recall by Novo Nordisk Inc, reported 2021-04-21, distributed nationwide. Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with sto
| Recall number | D-0621-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novo Nordisk Inc, Plainsboro, NJ, United States |
| Recall initiated | 2021-03-22 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-12-09 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| NDC | 00169-2550, 00169-2550-13, 00169-2550-90, 00169-2550-97, 00169-2660, 00169-2660-15, 00169-2660-90, 00169-2660-97, 00169-2662, 00169-2662-11, 00169-2662-90 |
| Expiration dates | 2021-08-16, 2021-09-30, 2021-11-30, 2022-07-31, 2022-11-30 |
Product
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0621-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.