FDA daily

FDA daily for Wednesday, February 26, 2025

In this issue: 24 approvals, 1 drug recall, 19 device recalls, 28 device decisions, 129 label changes and 29 food or supplement recalls. 3 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, Feb 19 FDA approved 2 new applications (1 brand or biologic, 1 generic) and 22 supplements to existing ones.

Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Feb 19 lists 1 drug recall: 1 Class II.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 19 device recalls from 5 firms on Wed, Feb 19.

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Device clearances and approvals

FDA date:

FDA decided 12 510(k)s and 16 PMA decisions on Wed, Feb 12.

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Label updates

FDA date:

129 drug labels took effect on Wed, Feb 12; 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, Feb 19 lists 29 food or supplement recalls: 7 Class I, 18 Class II, 4 Class III.

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.