FDA daily

FDA daily for Thursday, October 1, 2026

In this issue: 6 shortage updates, 17 approvals, 8 device recalls, 27 device decisions and 10 label changes.

Drug shortages

FDA date:

FDA updated 6 shortage entries on Wed, Sep 30: 5 resolved, 1 status update.

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Drug and biologic approvals

FDA date:

On Thu, Sep 24 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 14 supplements to existing ones.

  • PHENYLEPHRINE HYDROCHLORIDE

    NEPHRON · PHENYLEPHRINE HYDROCHLORIDE

    ANDA215268Generic (ANDA)Prescription
  • CRISABOROLE

    MACLEODS PHARMS · CRISABOROLE

    ANDA216242Generic (ANDA)Prescription
  • LINACLOTIDE

    ACTAVIS LABS FL · LINACLOTIDE

    ANDA211255Generic (ANDA)Prescription
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Device recalls

FDA date:

FDA posted 8 device recalls from 2 firms on Thu, Sep 24.

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Device clearances and approvals

FDA date:

FDA decided 18 510(k)s and 9 PMA decisions on Thu, Sep 17.

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Label updates

FDA date:

10 drug labels took effect on Thu, Sep 17.

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FDA did not answer for Food and supplement recalls, Drug recalls while this issue was written; those sections will fill in on a later visit.

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.