Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Biogen. FDA records under 2 spellings of its name, each linked to the record. See the Biogen group view.
As of Nov 14, 2026, FDA's public records list Biogen MA Inc. with 2 drug recalls and 2 drug applications. The most recent is a drug recall dated Dec 9, 2020: Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 9, 2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured fClass II · Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testin | Drug recalls |
| Jun 23, 2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142,Class III · cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
