Biogen MA Inc. recalls Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx
Biogen recalls Vumerity (diroximel fumarate) 231mg capsules due to failed dissolution testing. Affected bottles: 106-count and 120-count, Rx only. No remedy specified in recall notice.
Recall notice
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Contact the company & request your remedy
What happened, in plain English
Biogen is recalling Vumerity (diroximel fumarate) 231 mg capsules that failed dissolution testing. This means the medication may not work as intended when taken. The recall affects specific bottle counts and is for prescription-only use. Read more at govinfonow.com/recall/36617-biogen-vumerity-capsules-may-not-dissolve-properly.
Source Summary by GovInfoNow · govinfonow.com/recall/36617-biogen-vumerity-capsules-may-not-dissolve-properly · Updated October 4, 2026 · FDA enforcement record: FDA #D-0148-2021
Cite this page
“Biogen Vumerity Capsules May Not Dissolve Properly.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36617-biogen-vumerity-capsules-may-not-dissolve-properly. Based on FDA recall #D-0148-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0148-2021%22&limit=1).
Why it’s dangerous
The capsules failed dissolution testing during the buffer stage, meaning they may not release the medication properly in the body. This could lead to the medication not working as intended when taken. However, the recall does not specify if this causes serious harm.
Who’s affected
Prescription patients who have the 106-count or 120-count bottles of Vumerity capsules. Those with the specific lot numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check for Vumerity (diroximel fumarate) 231 mg capsules in 106-count or 120-count bottles. The product is prescription-only and has specific lot numbers and expiration dates listed in the recall.
- Brand
Biogen- Category
Drug
What to do — step by step
Check Product Details
Look for the 106-count or 120-count bottles of Vumerity capsules with the listed lot numbers and expiration dates.
Questions people ask
Is this product safe to take?
The recall does not specify if the product is unsafe; it indicates failed dissolution testing but does not state if this causes serious harm.
What should I do if I have this product?
The recall does not provide a remedy, so no specific action is required beyond checking if you have the affected product.
How can I tell if I have the recalled product?
Check for Vumerity 231 mg capsules in 106-count or 120-count bottles with the listed lot numbers and expiration dates.
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-0148-2021 — Biogen Biogen Hello, I own a Biogen that is covered by recall D-0148-2021 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-0148-2021 (December 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0148-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.