FDA Drug recall D-1381-2020
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142…
- FDA Drug
- Class III
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class III recall of Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142… by Biogen Ma, citing cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1381-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biogen Ma |
| Distribution | KY, MS, OH |
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
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Identifiers
| ndc | 64406-007-03 |
|---|---|
| ndc | 64406-005-01 |
| ndc | 64406-006-02 |
| code_info | Lot # SH0274, Exp 2/2022 |
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-1381-2020%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.