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FDA Daily

FDA daily for Friday, September 18, 2026

156 FDA records across 4 sections. 2 touch MedGrid's categories and are listed first.

156FDA Records
4 of 7Sections With Data
2Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Sep 17 (yesterday)
4
  • Methylphenidate Hydrochloride Tablet, Extended Release

    Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) — Janssen Pharmaceuticals

    Reverified · Current · Psychiatry

  • Methylphenidate Hydrochloride Tablet, Extended Release

    Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) — Janssen Pharmaceuticals

    Reverified · Current · Psychiatry

  • Methylphenidate Hydrochloride Tablet, Extended Release

    Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) — Janssen Pharmaceuticals

    Reverified · Current · Psychiatry

  • Methylphenidate Hydrochloride Tablet, Extended Release

    Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) — Janssen Pharmaceuticals

    Reverified · Current · Psychiatry

Drug approvalsCovers FDA's Fri, Sep 11 (a week ago)
18
  • MORPHINE SULFATE

    MORPHINE SULFATE — SPECGX LLC

    ANDA076438 · Labeling

  • PENTOSTATIN

    PENTOSTATIN — RISING

    ANDA203554 · Labeling

  • POLYETHYLENE GLYCOL 3350

    POLYETHYLENE GLYCOL 3350 — STRIDES PHARMA

    ANDA203928 · Manufacturing (CMC)

  • SIPONIMOD

    SIPONIMOD — RICONPHARMA LLC

    ANDA218444 · Labeling

  • CARBIDOPA AND LEVODOPA

    CARBIDOPA, LEVODOPA — SUN PHARM INDS

    ANDA078536 · Labeling

  • ISEMBYLD

    APITEGROMAB-MSTN — SCHOLAR ROCK INC

    BLA761463 · Original approval

  • KYBELLA

    DEOXYCHOLIC ACID — ABBVIE

    NDA206333 · Labeling

  • ETHOSUXIMIDE

    ETHOSUXIMIDE — CHARTWELL RX

    ANDA040506 · Labeling

  • DASATINIB

    DASATINIB — MSN

    ANDA219579 · Original approval

  • PACLITAXEL

    PACLITAXEL — TEVA PHARMS

    ANDA075184 · Labeling

  • PIXCLARA

    FLORETYROSINE F-18 — TELIX

    NDA218592 · Original approval

  • CARBIDOPA AND LEVODOPA

    CARBIDOPA, LEVODOPA — ACTAVIS ELIZABETH

    ANDA074260 · Labeling

Showing 12 of 18. Search the rest in openFDA.

Drug recallsCovers FDA's Fri, Sep 11 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Sep 11 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Sep 11 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Sep 4 (two weeks ago)
17
  • Digital Indeflator INFLANTE

    UAB Telemedicina

    K260035 · Substantially Equivalent · Cardiovascular

  • Peerbridge COR MDx (Cor MDx)

    Peerbridge Health, Inc.

    K253529 · Substantially Equivalent · Cardiovascular

  • ATTUNE Revision Knee System

    Depuy Orthopaedics, Inc.

    K262130 · Substantially Equivalent · Orthopedic

  • TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

    Sentinel Medical Technologies,

    K260756 · Substantially Equivalent · Gastroenterology, Urology

  • 70 NeuGlide Catheter

    Piraeus Medical, Inc.

    K262277 · Substantially Equivalent · Cardiovascular

  • NeoPEX™ Pre-Mixed Obturation Paste

    NuSmile, Ltd.

    K253909 · Substantially Equivalent · Dental

  • 3D-RD-S

    Radiopharmaceutical Imaging & Dosimetry, LLC

    K262060 · Substantially Equivalent · Radiology

  • ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexC…

    Medtronic Xomed, Inc.

    K262235 · Substantially Equivalent · Neurology

  • IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

    Siemens Healthcare Diagnostics Products, Ltd.

    K260331 · Substantially Equivalent · Immunology

  • Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

    Ortho Clinical Diagnostics Inc. (QuidelOrtho)

    K254262 · Substantially Equivalent · Microbiology

  • Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

    Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

    K254264 · Substantially Equivalent · Microbiology

  • NextMR Spine

    MRI2CT, Inc.

    K260525 · Substantially Equivalent · Radiology

Showing 12 of 17. Search the rest in openFDA.

Label changesCovers FDA's Fri, Sep 4 (two weeks ago)
2 touch MedGrid117
  • Nerve Guard Nerve ReliefTouches MedGrid categories

    Micelle Laboratories, Incorporated

    Label version 2

  • medroxyprogesterone acetateTouches MedGrid categories

    REMEDYREPACK INC.

    Label version 3

  • Citalopram

    REMEDYREPACK INC.

    Label version 2

  • Levetiracetam

    Cardinal Health 107, LLC

    Label version 7

  • FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS

    Harrow Eye, LLC

    Label version 4

  • Guanfacine

    REMEDYREPACK INC.

    Label version 3

  • NALTREXONE HYDROCHLORIDE

    SpecGx LLC

    Label version 15

  • Calamine

    United Natural Foods, Inc. dba UNFI

    Label version 8

  • Simethicone 125MG Gas Relief

    One2Zee Limited Liability Company

    Label version 2

  • Drug label

    Label version 5

  • DEFENCATH

    CorMedix Inc.

    Label version 8

  • Rufinamide

    American Health Packaging

    Label version 5

Showing 12 of 117. 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.

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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.