Biogen MA Inc. is recalling one specific lot consisting of 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg delayed-release capsules, a prescription medication used to treat multiple sclerosis. This recall was initiated because the affected lot was distributed to wholesalers and distributors in Kentucky, Ohio, and Mississippi despite having been rejected during internal quality control processes. Consumers should consult their healthcare provider or pharmacist regarding this recall and to arrange for a replacement if they possess the affected medication.
The product was released to the market despite failing in-process quality controls, which means the medication may not meet required safety or efficacy standards. While no specific injuries have been reported, using medication that has bypassed quality checks poses a risk of unpredictable treatment outcomes.
Healthcare consultation and pharmacy refund
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Sources: FDA iRES · Raw API Response
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