FDA daily

FDA daily for Wednesday, December 10, 2025

In this issue: 4 approvals, 16 drug recalls, 7 device recalls, 21 device decisions, 161 label changes and 7 food or supplement recalls. 5 items touch categories MedGrid carries, and they come first.

For MedGrid's categories

Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.

Drug and biologic approvals

FDA date:

On Wed, Dec 3 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 2 supplements to existing ones.

  • MACITENTAN

    MYLAN · MACITENTAN

    ANDA211161Generic (ANDA)Prescription
  • MACITENTAN

    LEPU PHARM · MACITENTAN

    ANDA211026Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Dec 3 lists 16 drug recalls: 1 Class I, 15 Class II.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 7 device recalls from 4 firms on Wed, Dec 3.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 13 510(k)s and 8 PMA decisions on Wed, Nov 26.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

161 drug labels took effect on Wed, Nov 26; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.

Browse label updates in FDA data →

Food and supplement recalls

FDA date:

FDA's enforcement report dated Wed, Dec 3 lists 7 food or supplement recalls: 4 Class I, 3 Class II.

Browse food and supplement recalls in FDA data →

How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.