Tremfya — Class III drug recall D-0314-2021
Terminated recall by Cardinal Health Inc., reported 2021-04-07, distributed in AL, LA, MS, TN. Temperature Abuse
| Recall number | D-0314-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-09 |
| Classified | 2021-03-29 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2021-11-04 |
| Distributed | AL, LA, MS, TN |
| Quantity | 48 boxes |
| Reason classes | temperature control |
| NDC | 57894-0640, 57894-0640-01, 57894-0640-03, 57894-0640-04, 57894-0640-06, 57894-0640-11, 57894-0640-99, 57894-0650, 57894-0650-01, 57894-0650-02, 57894-0651, 57894-0651-01, 57894-0651-02, 57894-0651-04, 57894-0651-11, 57894-0651-22, 57894-0651-92, 57894-0651-99 |
| Expiration dates | 2022-04 |
Product
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
Reason for recall
Temperature Abuse
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-0314-2021. 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.