Severity
Low
LowClass IIITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-1381-2020) was formally reported on July 15, 2020, with the manufacturer initiating the action on June 23, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Biogen Ma Inc. is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records list the affected scope as 3,922 bottles.
The documented reason for this recall is: cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. Distribution data in the federal record shows the product reached: Product was distributed to wholesalers/distributors in KY, OH & MS.. Distribution scope 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 - 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 - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
3,922 bottles
Related Recalls
6
0 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02. Recalled by Biogen Ma Inc.. Units affected: 3,922 bottles.
Why was this product recalled? ▼
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Low. Recall number: D-1381-2020.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to wholesalers/distributors in KY, OH & MS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1381-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 15, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.