CLASS II Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg recalled
Biogen MA is recalling Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, distributed nationwide in the US. The recall was initiated on 9 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0148-2021
- FDA event ID
- 86945
- Recalling firm
- Biogen MA, Research Triangle Park, NC
- Brand
- Vumerity
- Manufacturer
- Biogen Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2020
- FDA classified
- 14 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 9 Dec 2020 | Recall initiated by company | |
| 14 Dec 2020 | Classified by FDA | +5 days |
| 23 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01
Where it was distributed
USA Nationwide
Questions about this recall
Is Vumerity (diroximel fumarate) delayed-release capsule, 231 mg recalled?
Yes. Biogen MA recalled Vumerity (diroximel fumarate) delayed-release capsule, 231 mg on 9 Dec 2020. The recall is Class II and its status is Terminated. Recall number D-0148-2021.
Why was it recalled?
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Which lots are affected?
Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biogen MA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg recalledTecfidera | Biogen MA | Manufacturing (CGMP) Deviations | KY, MS, OH |