Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vumerity (diroximel fumarate) delayed-release capsule Recalled by Biogen MA Inc. Due to Failed dissolution specifications: out-of-specification test results observed during...

Date: December 9, 2020
Company: Biogen MA Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biogen MA Inc. directly.

Affected Products

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

Quantity: 5,307 bottles

Why Was This Recalled?

Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biogen MA Inc.

Biogen MA Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report