FDA Drug recall D-0148-2021
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured f…
- FDA Drug
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured f… by Biogen Ma, citing failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0148-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-09 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Biogen Ma |
| Distribution | US |
Product
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
Reason
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Identifiers
| ndc | 64406-020-01 |
|---|---|
| ndc | 64406-020-03 |
| ndc | 64406-020-05 |
| ndc | 64406-020-07 |
| code_info | Lot #: a) 101801, Exp 5/31/2021; 102826, Exp 6/21/2021; b) 101799, Exp 5/31/2021; 102362, Exp 6/21/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0148-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.