FDA Drug recall · Reported July 15, 2020
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Biogen Ma Inc. recalled Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only,… - a low-severity action.
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only,… was recalled by Biogen Ma Inc. in July 15, 2020. Reason: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-proces…. Check the official notice for the remedy. Verify recall #D-1381-2020 with the FDA Drug before acting.
The recall
Biogen Ma Inc. issued this low-severity FDA Drug recall-cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-proces….
- Low
- severity level
- Class III
- classification
- July 15, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1381-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,781 children & baby products recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02
Reason for recall
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1381-2020 |
| Date reported | July 15, 2020 |
| Date initiated | June 23, 2020 |
| Recalling firm | Biogen Ma Inc. |
| Firm location | Research Triangle Park, NC |
| Affected scope | 3,922 bottles |
| Distribution | Product was distributed to wholesalers/distributors in KY, OH & MS. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1381-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026