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FDA Daily

FDA daily for Monday, October 12, 2026

23 FDA records across 3 sections.

23FDA Records
3 of 7Sections With Data
0Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Sun, Oct 11 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Mon, Oct 5 (a week ago)
15
  • DEXMETHYLPHENIDATE HYDROCHLORIDE

    DEXMETHYLPHENIDATE HYDROCHLORIDE — IMPAX LABS INC

    ANDA079108 · Labeling

  • DOXEPIN HYDROCHLORIDE

    DOXEPIN HYDROCHLORIDE — ADAPTIS

    ANDA213796 · Labeling

  • TOPIRAMATE

    TOPIRAMATE — ALKEM LABS LTD

    ANDA217248 · Labeling

  • BUPROPION HYDROCHLORIDE

    BUPROPION HYDROCHLORIDE — SINOTHERAPEUTICS INC

    ANDA208652 · Labeling

  • CARBAMAZEPINE

    CARBAMAZEPINE — APOTEX

    ANDA213159 · Labeling

  • ACTHAR GEL

    CORTICOTROPIN — MALLINCKRODT IRELAND

    NDA008372 · Labeling

  • CORTROPHIN-ZINC

    CORTICOTROPIN-ZINC HYDROXIDE — ANI PHARMS

    NDA009854 · Labeling

  • DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

    AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE — LANNETT CO INC

    ANDA214403 · Labeling

  • DICLOFENAC SODIUM

    DICLOFENAC SODIUM — ENCUBE

    ANDA210986 · Labeling

  • TOPIRAMATE

    TOPIRAMATE — AJANTA PHARMA LTD

    ANDA215663 · Labeling

  • CARBAMAZEPINE

    CARBAMAZEPINE — TORRENT

    ANDA212524 · Labeling

  • PURIFIED CORTROPHIN GEL

    CORTICOTROPIN — ANI PHARMS

    NDA008975 · Labeling

Showing 12 of 15. Search the rest in openFDA.

Drug recallsCovers FDA's Mon, Oct 5 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Mon, Oct 5 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Mon, Oct 5 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Mon, Sep 28 (two weeks ago)
5
  • Tri Stage Venous Cannulae

    Sorin Group Italia S.R.L.

    K262052 · Substantially Equivalent · Cardiovascular

  • Alians Forearm

    Newclip Technics

    K262649 · Substantially Equivalent · Orthopedic

  • Phasix ST Parastomal Hernia Mesh

    Davol, Inc., A Subsidiary of C.R. Bard, Inc.

    K261543 · Substantially Equivalent · General, Plastic Surgery

  • Liora Monofilament Scaffold

    TELA Bio, Inc.

    K260474 · Substantially Equivalent · General, Plastic Surgery

  • VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)

    Biomérieux, Inc.

    K260619 · Substantially Equivalent · Microbiology

Label changesCovers FDA's Mon, Sep 28 (two weeks ago)
3
  • Drug label

    Label version 3

  • Drug label

    Label version 5

  • Drug label

    Label version 6

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.