Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Tecfidera (dimethyl fumarate) delayed-release capsules Recalled by Biogen MA Inc. Due to cGMP deviations: one lot of the product was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biogen MA Inc. directly.
Affected Products
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Quantity: 3,922 bottles
Why Was This Recalled?
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Where Was This Sold?
This product was distributed to 3 states: KY, MS, OH
About Biogen MA Inc.
Biogen MA Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report