Medications & Supplements/Prescription Drugs

Biogen MA Inc.: Vumerity (diroximel fumarate) Recalled for Failed Dissolution Testing

Agency Publication Date: December 14, 2020

Summary

Biogen MA Inc. has voluntarily recalled 5,307 bottles of Vumerity (diroximel fumarate) 231 mg delayed-release capsules because the medication failed quality testing for dissolution. This means the drug may not break down correctly in the body at the intended stage, which can affect how the medication is absorbed. This recall affects both 106-count and 120-count bottles distributed nationwide across the United States.

Risk

If the medication fails to dissolve according to specifications during the buffer stage, it may not deliver the correct dosage at the right time, potentially reducing the effectiveness of the treatment for the patient's condition.

What You Should Do

Check your medication bottle for the product name Vumerity (diroximel fumarate) delayed-release capsules, 231 mg, with NDC 64406-020-01.
Verify the lot number and expiration date on your packaging. Affected 106-count bottles include lot 101801 (Exp 5/31/2021) and lot 102826 (Exp 6/21/2021). Affected 120-count bottles include lot 101799 (Exp 5/31/2021) and lot 102362 (Exp 6/21/2021).
Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.
Return any unused portions of the affected lots to your pharmacy to receive a refund.
Contact Biogen MA Inc. directly at their Research Triangle Park location or via the contact information provided by your pharmacist for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Vumerity (diroximel fumarate) delayed-release capsule, 231 mg (106-count bottle)

Model:

NDC 64406-020-01

Lot Numbers:

101801 (Exp 5/31/2021)

102826 (Exp 6/21/2021)

Date Ranges: Expiration 5/31/2021, Expiration 6/21/2021

Product: Vumerity (diroximel fumarate) delayed-release capsule, 231 mg (120-count bottle)

Model:

NDC 64406-020-01

Lot Numbers:

101799 (Exp 5/31/2021)

102362 (Exp 6/21/2021)

Date Ranges: Expiration 5/31/2021, Expiration 6/21/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86945

Status: Resolved

Manufacturer: Biogen MA Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5,307 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle for the product name Vumerity (diroximel fumarate) delayed-release capsules, 231 mg, with NDC 64406-020-01.

Verify the lot number and expiration date on your packaging. Affected 106-count bottles include lot 101801 (Exp 5/31/2021) and lot 102826 (Exp 6/21/2021). Affected 120-count bottles include lot 101799 (Exp 5/31/2021) and lot 102362 (Exp 6/21/2021).

Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if a replacement prescription is necessary.

Return any unused portions of the affected lots to your pharmacy to receive a refund.

Contact Biogen MA Inc. directly at their Research Triangle Park location or via the contact information provided by your pharmacist for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Vumerity (diroximel fumarate) delayed-release capsule, 231 mg (106-count bottle)

Model:

NDC 64406-020-01

Lot Numbers:

101801 (Exp 5/31/2021)

102826 (Exp 6/21/2021)

Date Ranges: Expiration 5/31/2021, Expiration 6/21/2021

Product: Vumerity (diroximel fumarate) delayed-release capsule, 231 mg (120-count bottle)

Model:

NDC 64406-020-01

Lot Numbers:

101799 (Exp 5/31/2021)

102362 (Exp 6/21/2021)

Date Ranges: Expiration 5/31/2021, Expiration 6/21/2021