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FDA Daily

FDA daily for Thursday, September 24, 2026

107 FDA records across 3 sections. 11 touch MedGrid's categories and are listed first.

107FDA Records
3 of 7Sections With Data
11Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Sep 23 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Thu, Sep 17 (a week ago)
2 touch MedGrid15
  • AMABELZTouches MedGrid categories

    ESTRADIOL, NORETHINDRONE ACETATE — LUPIN

    ANDA203339 · Labeling

  • SPRAVATOTouches MedGrid categories

    ESKETAMINE HYDROCHLORIDE — JANSSEN PHARMS

    NDA211243 · Labeling

  • DAPTOMYCIN

    DAPTOMYCIN — FRESENIUS KABI USA

    ANDA213396 · Labeling

  • DEXTROAMPHETAMINE SULFATE

    DEXTROAMPHETAMINE SULFATE — ACTAVIS ELIZABETH

    ANDA203901 · Labeling

  • IMATINIB MESYLATE

    IMATINIB MESYLATE — APOTEX

    ANDA079179 · Labeling

  • TOPIRAMATE

    TOPIRAMATE — UNICHEM LABS LTD

    ANDA090162 · Labeling

  • SULFAMETHOXAZOLE AND TRIMETHOPRIM

    SULFAMETHOXAZOLE, TRIMETHOPRIM — GLENMARK PHARMS LTD

    ANDA090828 · Labeling

  • LEVOCETIRIZINE DIHYDROCHLORIDE

    LEVOCETIRIZINE DIHYDROCHLORIDE — APOTEX

    ANDA202915 · Labeling

  • CYCLOSPORINE

    CYCLOSPORINE — AUROBINDO PHARMA LTD

    ANDA219652 · Original approval

  • ICOSAPENT ETHYL

    ICOSAPENT ETHYL — APOTEX

    ANDA209437 · Labeling

  • LACOSAMIDE

    LACOSAMIDE — ZYDUS PHARMS

    ANDA209465 · Labeling

  • LEVOCETIRIZINE DIHYDROCHLORIDE

    LEVOCETIRIZINE DIHYDROCHLORIDE — APOTEX

    ANDA203027 · Labeling

Showing 12 of 15. Search the rest in openFDA.

Drug recallsCovers FDA's Thu, Sep 17 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Sep 17 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Sep 17 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Sep 10 (two weeks ago)
2 touch MedGrid16
  • Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Touches MedGrid categories

    Wuhan Pioon Technology Co., Ltd.

    K262426 · Substantially Equivalent · General, Plastic Surgery

  • Diode Laser Therapy SystemTouches MedGrid categories

    Sanhe LEFIS Electronics Co., Ltd.

    K261562 · Substantially Equivalent · General, Plastic Surgery

  • TruPress

    Procerus Enterprises

    K254074 · Substantially Equivalent · Cardiovascular

  • BioTeke® Multi-Drug Urine Test Cup

    Bioteke Corporation (Wuxi) Co., Ltd.

    K261409 · Substantially Equivalent · Clinical Toxicology

  • Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    Koh Young Technology, Inc.

    K253856 · Substantially Equivalent · Neurology

  • danumed Extension Set for Gastrostomy Button

    Danumed Medizintechnik GmbH

    K260110 · Substantially Equivalent · Gastroenterology, Urology

  • 4K Camera Head OLYMPUS CH-S700-08-LB

    Olympus Medical Systems Corp.

    K262079 · Substantially Equivalent · Gastroenterology, Urology

  • EVOLUTION MPX™ Total Knee System

    Suzhou Microport Orthorecon Co., Ltd.

    K262293 · Substantially Equivalent · Orthopedic

  • Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

    Lakong Medical Devices Co., Ltd.

    K254009 · Substantially Equivalent · Dental

  • LT Antibacterial Foam with Silver Dressing

    Zhejiang Longterm Medical Technology Co., Ltd.

    K254246 · Substantially Equivalent · General, Plastic Surgery

  • Quicktome Software Suite

    Omniscient Neurotechnology Pty, Ltd.

    K261795 · Substantially Equivalent · Radiology

  • ACUNAV Luxera 4D ICE Catheter

    Siemens Medical Solutions USA, Inc.

    K261696 · Substantially Equivalent · Cardiovascular

Showing 12 of 16. Search the rest in openFDA.

Label changesCovers FDA's Thu, Sep 10 (two weeks ago)
7 touch MedGrid76
  • LIDOCAINE HYDROCHLORIDETouches MedGrid categories

    Henry Schein, Inc.

    Label version 6

  • Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45Touches MedGrid categories

    Kenvue Brands LLC

    Label version 12

  • BCBCYC Numbing CreamTouches MedGrid categories

    Wenzhou Yuyuan Pharmaceutical Co., Ltd.

    Label version 2

  • JenGufun LIDOCAINE KNEE PatchTouches MedGrid categories

    Henan Kangdi Medical Devices Co., Ltd.

    Label version 1

  • Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30Touches MedGrid categories

    Kenvue Brands LLC

    Label version 13

  • Flarestop Hemorrhoid LidocaineTouches MedGrid categories

    Chelsea Pharmacceuticals LLC

    Label version 1

  • Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30Touches MedGrid categories

    Kenvue Brands LLC

    Label version 13

  • METOPROLOL TARTRATE

    REMEDYREPACK INC.

    Label version 1

  • Xarelto

    Janssen Pharmaceuticals, Inc.

    Label version 65

  • Gabapentin

    REMEDYREPACK INC.

    Label version 3

  • Cough and Cold HBP

    Geiss, Destin & Dunn Inc.

    Label version 4

  • Glatiramer Acetate

    AJENAT PHARMACEUTICALS LLC

    Label version 3

Showing 12 of 76. Search the rest in openFDA.

How the FDA Daily Is WrittenSources, dates and what gets flagged

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 recalls, 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. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

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.