Tecfidera — Class III drug recall D-1381-2020
Terminated recall by Biogen MA Inc., reported 2020-07-15, distributed in KY, MS, OH. cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process
| Recall number | D-1381-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biogen MA Inc., Research Triangle Park, NC, United States |
| Recall initiated | 2020-06-23 |
| Classified | 2020-07-09 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-02-11 |
| Distributed | KY, MS, OH |
| Quantity | 3,922 bottles |
| Reason classes | cgmp |
| NDC | 64406-0005, 64406-0005-01, 64406-0006, 64406-0006-02, 64406-0007, 64406-0007-03 |
| Lot numbers | SH0274 |
| Expiration dates | 2022-02 |
Product
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Reason for recall
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
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-1381-2020. 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.