Biogen Recalls Tecfidera Capsules Due to Quality Control Deviations
Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences. The issue is a documentation and quality control deviation (distribution of a rejected lot) rather than a confirmed contamination or defect causing harm.
Plain-English summary
Biogen MA Inc. is voluntarily recalling 3,922 bottles of Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottles. The affected product is identified by Lot # SH0274 with an expiration date of 2/2022. The product is a prescription-only medication manufactured by Biogen Inc. in Cambridge, MA.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, one lot of the product was distributed to US markets despite being rejected during in-process control. The product was distributed to wholesalers and distributors in Kentucky, Ohio, and Mississippi.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or distributor. No specific instructions for patients currently taking the medication are provided in the source text, but patients should consult their healthcare provider for guidance.
The recalled product
- Product
- TECFIDERA (DIMETHYL FUMARATE)
- Brand
- TECFIDERA
- Manufacturer
- Biogen MA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 3,922
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 (2)
- Lot # SH0274
- Exp 2/2022
UPCs (3)
- 0364406005015
- 0364406005107
- 0364406005084
Distribution
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