FDA daily

FDA daily for Wednesday, September 23, 2026

In this issue: 32 shortage updates, 14 approvals, 4 drug recalls, 40 device recalls, 19 device decisions, 198 label changes and 5 food or supplement recalls. 8 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 32 shortage entries on Tue, Sep 22: 32 status updates.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Wed, Sep 16 FDA approved no new applications and 14 supplements to existing ones.

  • CALCITRIOL

    ONESOURCE SPECIALTY · CALCITRIOL

    ANDA091356Generic (ANDA)Prescription
  • XELJANZ

    PFIZER · TOFACITINIB CITRATE

    NDA213082Drug (NDA)Prescription
  • GABAPENTIN

    PAI HOLDINGS PHARM · GABAPENTIN

    ANDA211330Generic (ANDA)Prescription
  • DEXTROAMPHETAMINE SULFATE

    STRIDES PHARMA · DEXTROAMPHETAMINE SULFATE

    ANDA205077Generic (ANDA)Discontinued
  • XELJANZ XR

    PFIZER · TOFACITINIB CITRATE

    NDA208246Drug (NDA)Prescription
  • XELJANZ

    PF PRISM CV · TOFACITINIB CITRATE

    NDA203214Drug (NDA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Sep 16 lists 4 drug recalls: 1 Class I, 2 Class III.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 40 device recalls from 12 firms on Wed, Sep 16.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 8 510(k)s and 11 PMA decisions on Wed, Sep 9.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

198 drug labels took effect on Wed, Sep 9. 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 16 lists 5 food or supplement recalls: 3 Class I, 2 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.