Vumerity — Class II drug recall D-0148-2021
Terminated recall by Biogen MA Inc., reported 2020-12-23, distributed nationwide. Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolut
| Recall number | D-0148-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biogen MA Inc., Research Triangle Park, NC, United States |
| Recall initiated | 2020-12-09 |
| Classified | 2020-12-14 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2021-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 5,307 bottles |
| Reason classes | specification failure |
| NDC | 64406-0020, 64406-0020-01, 64406-0020-03, 64406-0020-05, 64406-0020-07 |
| Expiration dates | 2021-05-31, 2021-06-21 |
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 for recall
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0148-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.