FDA daily

FDA daily for Wednesday, November 11, 2026

In this issue: 8 shortage updates, 5 approvals, 35 drug recalls, 4 device recalls, 29 device decisions, 207 label changes and 12 food or supplement recalls. 6 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 8 shortage entries on Tue, Nov 10: 8 status updates.

Browse drug shortages in FDA data →

Drug and biologic approvals

FDA date:

On Wed, Nov 4 FDA approved no new applications and 5 supplements to existing ones.

  • EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

    MACLEODS PHARMS · EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE

    ANDA203442Generic (ANDA)Prescription
  • IRBESARTAN

    PRINSTON INC · IRBESARTAN

    ANDA203071Generic (ANDA)Prescription
  • ZYNLONTA

    ADC Therapeutics SA · LONCASTUXIMAB TESIRINE-LPYL

    BLA761196Biologic (BLA)Prescription
  • ORGOVYX

    SUMITOMO PHARMA AM · RELUGOLIX

    NDA214621Drug (NDA)Prescription
  • RELEUKO

    KASHIV BIOSCIENCES LLC · FILGRASTIM-AYOW

    BLA761082Biologic (BLA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, Nov 4 lists 35 drug recalls: 31 Class II, 3 Class III.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 4 device recalls from 2 firms on Wed, Nov 4.

  • Senographe Pristina

    GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…

    Open, ClassifiedRadiation Control for Health and Safety ActZ-0326-2027
  • Senographe Pristina

    GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…

    Open, ClassifiedRadiation Control for Health and Safety ActZ-0327-2027
  • Senographe Pristina 3D

    GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…

    Open, ClassifiedRadiation Control for Health and Safety ActZ-0328-2027
  • intelerad IntelePACS software

    INTELERAD MEDICAL SYSTEMS INCORPORATED · A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify ima…

    Open, ClassifiedSoftware Design ChangeZ-0357-2027
Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 15 510(k)s and 14 PMA decisions on Wed, Oct 28.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

207 drug labels took effect on Wed, Oct 28; 6 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, Nov 4 lists 12 food or supplement recalls: 9 Class I, 3 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.