# FDA recall D-1381-2020

> **Biogen MA Inc.** · Class III · drug recall initiated 2020-06-23.

## Product

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.

## Distribution

Product was distributed to wholesalers/distributors in KY, OH & MS.

## Key facts

- **Recall number:** D-1381-2020
- **Recalling firm:** Biogen MA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-23
- **Report date:** 2020-07-15
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Research Triangle Park, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2020

## Citation

> AI Analytics. FDA recall D-1381-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1381-2020. Source: US FDA. Licensed CC0.

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