FDA daily

FDA daily for Wednesday, September 30, 2026

In this issue: 2 shortage updates, 15 approvals, 11 drug recalls, 7 device recalls, 35 device decisions, 4 label changes and 49 food or supplement recalls.

Drug shortages

FDA date:

FDA updated 2 shortage entries on Tue, Sep 29: 1 new, 1 to be discontinued.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Wed, Sep 23 FDA approved 5 new applications (2 brand or biologic, 3 generic) and 10 supplements to existing ones.

  • LYRFIGTU

    ELEVAR THERAPEUTICS INC · LIRAFUGRATINIB HYDROCHLORIDE

    NDA220425Drug (NDA)Prescription
  • NORGESTIMATE AND ETHINYL ESTRADIOL

    ANNORA PHARMA · ETHINYL ESTRADIOL, NORGESTIMATE

    ANDA220876Generic (ANDA)Prescription
  • KETOROLAC TROMETHAMINE

    SHANDONG · KETOROLAC TROMETHAMINE

    ANDA218355Generic (ANDA)Prescription
  • ONSWIK

    ELI LILLY AND CO · INSULIN EFSITORA ALFA-GOBE

    BLA761408Biologic (BLA)Prescription
  • MEXILETINE HYDROCHLORIDE

    ZYDUS PHARMS · MEXILETINE HYDROCHLORIDE

    ANDA214598Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Sep 23 lists 11 drug recalls: 1 Class I, 9 Class II.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 7 device recalls from 5 firms on Wed, Sep 23.

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Device clearances and approvals

FDA date:

FDA decided 24 510(k)s and 11 PMA decisions on Wed, Sep 16.

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Label updates

FDA date:

4 drug labels took effect on Wed, Sep 16. 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 23 lists 49 food or supplement recalls: 40 Class I, 7 Class II, 1 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.