Biogen MA Inc. recalls Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,
Biogen recalls Tecfidera 240mg capsules due to a manufacturing issue that may have led to contaminated product distribution. Affected lots were distributed despite in-process rejection.
Lower-risk recall
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Contact the company & request your remedy
What happened, in plain English
Biogen is recalling Tecfidera (dimethyl fumarate) delayed-release capsules that were distributed despite being rejected during manufacturing checks. This could mean the product contains contaminants that might cause harm if taken. Read more at govinfonow.com/recall/36999-biogen-tecfidera-capsules-recall-risk-of-contaminated-product.
Source Summary by GovInfoNow · govinfonow.com/recall/36999-biogen-tecfidera-capsules-recall-risk-of-contaminated-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-1381-2020
Cite this page
“Biogen Tecfidera Capsules Recall: Risk of Contaminated Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36999-biogen-tecfidera-capsules-recall-risk-of-contaminated-product. Based on FDA recall #D-1381-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1381-2020%22&limit=1).
Why it’s dangerous
The product was distributed to US markets even though it was rejected during manufacturing quality checks. This could mean the product contains contaminants that might cause harm if taken.
Who’s affected
People with a prescription for Tecfidera who received the specific lot number SH0274 from Biogen. Those who have taken the product since its distribution may be at risk.
How to tell if you have this one
Check for the lot number SH0274 on the product label. The product is a 240 mg delayed-release capsule, 60-count bottle, prescription-only, manufactured by Biogen Inc. in Cambridge, MA.
- Brand
Biogen- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number SH0274 on the Tecfidera capsule bottle.
Questions people ask
Is this product safe to take?
The recall states the product was distributed despite being rejected during manufacturing checks, which could mean it contains contaminants. However, the official notice does not specify if the product is safe to take.
How do I know if I have the recalled product?
Check the product label for lot number SH0274. The product is a 240 mg delayed-release capsule, 60-count bottle, prescription-only, manufactured by Biogen Inc. in Cambridge, MA.
What should I do if I have the recalled product?
The recall does not specify a remedy, so the official notice does not say what to do with the product.
Contact Biogen
We’ve drafted a message you can send Biogen to request your refund or repair — edit it as you like.
Subject: Recall D-1381-2020 — Biogen Biogen Hello, I own a Biogen that is covered by recall D-1381-2020 from Biogen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1381-2020 (June 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1381-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.