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Biogen MA recalls

Biogen MA has 2 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 23 Dec 2020. The most frequent reason is potency & assay.

Total recalls2since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 23 Dec 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why biogen ma is recalled

Potency & Assay150%
Manufacturing (CGMP) Deviations150%

Brands

Tecfidera150%
Vumerity150%

By year

20202100%

All biogen ma recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Drug	CLASS II	Vumerity (diroximel fumarate) delayed-release capsule, 231 mg recalledVumerity	Biogen MA	Potency & Assay	Nationwide
15 Jul 2020Drug	CLASS III	Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg recalledTecfidera	Biogen MA	Manufacturing (CGMP) Deviations	KY, MS, OH

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.