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FDA Daily

FDA daily for Friday, September 25, 2026

42 FDA records across 3 sections.

42FDA Records
3 of 7Sections With Data
0Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Sep 24 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Fri, Sep 18 (a week ago)
8
  • INLURIYO

    IMLUNESTRANT TOSYLATE — ELI LILLY AND CO

    NDA218881 · Efficacy

  • SOHONOS

    PALOVAROTENE — IPSEN

    NDA215559 · Labeling

  • AQNEURSA

    LEVACETYLLEUCINE — INTRABIO

    NDA219132 · Efficacy

  • DICLOFENAC POTASSIUM

    DICLOFENAC POTASSIUM — RUBICON RESEARCH

    ANDA075229 · Manufacturing (CMC)

  • VERZENIO

    ABEMACICLIB — ELI LILLY AND CO

    NDA208716 · Efficacy

  • LANREOTIDE ACETATE

    LANREOTIDE ACETATE — AMNEAL

    ANDA218217 · Original approval

  • DEFLAZACORT

    DEFLAZACORT — HIKMA

    ANDA220524 · Original approval

  • ROCURONIUM BROMIDE

    ROCURONIUM BROMIDE — BAXTER HLTHCARE CORP

    ANDA219260 · Original approval

Drug recallsCovers FDA's Fri, Sep 18 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Sep 18 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Sep 18 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Sep 11 (two weeks ago)
29
  • SkinSmart Antimicrobial HydroGel

    Magic Science Supply, LLC

    K254041 · Substantially Equivalent · Unknown

  • MICSI-PET

    Microstructure Imaging, Inc.

    K261305 · Substantially Equivalent · Radiology

  • DRIM-Nail System

    41Medical AG

    K260115 · Substantially Equivalent · Unknown

  • Mg OSTEOREVIVE™;Mg OSTEOCRETE™

    Bone Solutions, Inc.

    K262230 · Substantially Equivalent · Orthopedic

  • Ecomed Disposable Administration Sets

    Ecomed Solutions, LLC

    K254123 · Substantially Equivalent · General Hospital

  • Sequential Circulator (SC-4004-DL, SC-4008-DL)

    Bio Compression Systems, Inc.

    K261807 · Substantially Equivalent · Cardiovascular

  • FINDER Flu A&B/SARS-CoV-2 Test

    Baebies, Inc.

    K261837 · Substantially Equivalent · Microbiology

  • iLet Dosing Decision Software

    Beta Bionics, Inc.

    K262763 · Substantially Equivalent · Clinical Chemistry

  • PureLift Pro Max

    Xtreem Pulse, LLC

    K262861 · Substantially Equivalent · Neurology

  • Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF S…

    INNO Holdings Inc. DBA Innovasis

    K262025 · Substantially Equivalent · Orthopedic

  • SpaceOAR Flex™ System

    Boston Scientific Corporation

    K262151 · Substantially Equivalent · Radiology

  • Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202)…

    Shenzhen Xinyan Medical Technology Co.,ltd.

    K254119 · Substantially Equivalent · Cardiovascular

Showing 12 of 29. Search the rest in openFDA.

Label changesCovers FDA's Fri, Sep 11 (two weeks ago)
5
  • Drug label

    Label version 9

  • gabapentin

    REMEDYREPACK INC.

    Label version 2

  • Antiseptic

    WALMART INC. (see also Equate)

    Label version 5

  • Pregabalin

    REMEDYREPACK INC.

    Label version 3

  • Folic Acid

    REMEDYREPACK INC.

    Label version 3

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.

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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.