Biogen Recalls Vumerity Capsules Due to Dissolution Test Failures
Biogen is recalling 5,307 bottles of Vumerity capsules because they failed dissolution testing. The medication may not release the drug as intended.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a quality control failure (dissolution) that may affect drug efficacy, but no specific injuries or illnesses are reported in the source text, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Biogen MA Inc. is recalling 5,307 bottles of Vumerity (diroximel fumarate) delayed-release capsules, 231 mg. The recall involves 106-count and 120-count bottles distributed nationwide in the United States. The specific lots affected are 101801, 102826, 101799, and 102362, with expiration dates of May 31, 2021, and June 21, 2021.
The recall was initiated because out-of-specification test results were observed during buffer stage dissolution testing. This means the capsules may not dissolve and release the medication in the body as required by quality standards.
Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VUMERITY (DIROXIMEL FUMARATE)
- Brand
- VUMERITY
- Manufacturer
- Biogen MA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 5,307
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: a) 101801
- Exp 5/31/2021
- 102826
- Exp 6/21/2021
- b) 101799
- 102362
UPCs (1)
- 0364406020032
Distribution
Distributed nationwide across the United States.
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