FDA daily

FDA daily for Wednesday, September 16, 2026

In this issue: 44 shortage updates, 3 approvals, 34 drug recalls, 2 device recalls, 22 device decisions, 150 label changes and 20 food or supplement recalls. 7 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 shortages

FDA date:

FDA updated 44 shortage entries on Tue, Sep 15: 44 status updates.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Wed, Sep 9 FDA approved no new applications and 3 supplements to existing ones.

  • HYRNUO

    BAYER HEALTHCARE · SEVABERTINIB

    NDA219972Drug (NDA)Prescription
  • ROPINIROLE HYDROCHLORIDE

    ALEMBIC LTD · ROPINIROLE HYDROCHLORIDE

    ANDA090429Generic (ANDA)Prescription
  • AMELUZ

    BIOFRONTERA · AMINOLEVULINIC ACID HYDROCHLORIDE

    NDA208081Drug (NDA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Sep 9 lists 34 drug recalls: 2 Class I, 28 Class II, 4 Class III.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 2 device recalls from 1 firm on Wed, Sep 9.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 14 510(k)s and 8 PMA decisions on Wed, Sep 2.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

150 drug labels took effect on Wed, Sep 2; 1 of the 25 read for this issue is 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, Sep 9 lists 20 food or supplement recalls: 7 Class I, 4 Class II, 9 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.