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FDA Daily

FDA daily for Thursday, September 17, 2026

193 FDA records across 4 sections. 6 touch MedGrid's categories and are listed first.

193FDA Records
4 of 7Sections With Data
6Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Sep 16 (yesterday)
1 touch MedGrid32
  • Lidocaine Hydrochloride InjectionTouches MedGrid categories

    Lidocaine Hydrochloride, Injection, 20 mg/1 mL (NDC 76329-3390-1) — Amphastar Pharmaceuticals, Inc.

    Reverified · Current · Anesthesia

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 60505-4739-1) — Apotex Corp.

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Tablet, Chewable

    Lisdexamfetamine Dimesylate, Tablet, Chewable, 50 mg (NDC 72205-136-91) — Novadoz Pharmaceuticals LLC

    Reverified · Current · Psychiatry

  • Dexmedetomidine Hydrochloride Injection

    Dexmedetomidine Hydrochloride, Injection, 400 mcg/100 mL (4 ug/1 mL) (NDC 72572-128-08) — Azurity Pharmaceuticals, Inc

    Reverified · Current · Anesthesia

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 60505-4742-1) — Apotex Corp.

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Tablet, Chewable

    Lisdexamfetamine Dimesylate, Tablet, Chewable, 20 mg (NDC 72205-133-91) — Novadoz Pharmaceuticals LLC

    Reverified · Current · Psychiatry

  • Dobutamine Hydrochloride Injection

    Dobutamine Hydrochloride, Injection, 250 mg/20 mL (NDC 70436-203-80) — Hainan Poly Pharm. Co., Ltd.

    Reverified · Current · Cardiovascular

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 72516-011-01) — Oryza Pharmaceuticals Inc.

    Reverified · Current · Psychiatry

  • Conivaptan Hydrochloride Injection

    Vaprisol Dextrose In Plastic Container, Injection, 20 mg/100 mL (NDC 66220-160-10) — Cumberland Pharmaceuticals Inc.

    Reverified · Current · Cardiovascular

  • Lisdexamfetamine Dimesylate Tablet, Chewable

    Lisdexamfetamine Dimesylate, Tablet, Chewable, 40 mg (NDC 72205-135-91) — Novadoz Pharmaceuticals LLC

    Reverified · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 72516-014-01) — Oryza Pharmaceuticals Inc.

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 60505-4743-1) — Apotex Corp.

    Reverified · Current · Psychiatry

Showing 12 of 32. Search the rest in openFDA.

Drug approvalsCovers FDA's Thu, Sep 10 (a week ago)
1 touch MedGrid10
  • ANNOVERATouches MedGrid categories

    ETHINYL ESTRADIOL, SEGESTERONE ACETATE — MAYNE PHARMA

    NDA209627 · Labeling

  • LISDEXAMFETAMINE DIMESYLATE

    LISDEXAMFETAMINE DIMESYLATE — PRINSTON INC

    ANDA216266 · Labeling

  • LISDEXAMFETAMINE DIMESYLATE

    LISDEXAMFETAMINE DIMESYLATE — GRANULES

    ANDA218987 · Labeling

  • ISOTRETINOIN

    ISOTRETINOIN — AUROBINDO PHARMA LTD

    ANDA220336 · Original approval

  • HYDROMORPHONE HYDROCHLORIDE

    HYDROMORPHONE HYDROCHLORIDE — HIKMA

    ANDA074597 · Labeling

  • ASENAPINE MALEATE

    ASENAPINE MALEATE — ALEMBIC

    ANDA206098 · Manufacturing (CMC)

  • LISDEXAMFETAMINE DIMESYLATE

    LISDEXAMFETAMINE DIMESYLATE — ASCENT PHARMS INC

    ANDA217442 · Labeling

  • HYDROMORPHONE HYDROCHLORIDE

    HYDROMORPHONE HYDROCHLORIDE — HIKMA

    ANDA074653 · Labeling

  • LISDEXAMFETAMINE DIMESYLATE

    LISDEXAMFETAMINE DIMESYLATE — ASCENT PHARMS INC

    ANDA217068 · Labeling

  • SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

    HYDROCHLOROTHIAZIDE, SPIRONOLACTONE — RUBICON RESEARCH

    ANDA220884 · Original approval

Drug recallsCovers FDA's Thu, Sep 10 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Sep 10 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Sep 10 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Sep 3 (two weeks ago)
1 touch MedGrid15
  • Tenax® Laser Resistant Endotracheal TubeTouches MedGrid categories

    Bryan Medical, Inc.

    K251794 · Substantially Equivalent · Anesthesiology

  • Helo Max Thrombectomy System (HEL2090)

    Endovascular Engineering

    K261800 · Substantially Equivalent · Cardiovascular

  • Tempo Plating System; Ultra Compression Screw System

    Pace Surgical

    K261647 · Substantially Equivalent · Orthopedic

  • Queen of Hearts (ACS AI ECG Model)

    Powerful Medical, Inc.

    DEN250044 · Unknown · Unknown

  • NeuroBlate System

    Monteris Medical

    K262315 · Substantially Equivalent · General, Plastic Surgery

  • Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)

    Orthocon, Inc.

    K262769 · Substantially Equivalent · Unknown

  • HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water b…

    Maxigen Biotech, Inc.

    K253989 · Substantially Equivalent · Obstetrics/Gynecology

  • Triton 1 System

    Neptune Medical, Inc.

    K260503 · Substantially Equivalent · Gastroenterology, Urology

  • Rezum System

    Boston Scientific

    K262460 · Substantially Equivalent · Gastroenterology, Urology

  • Happy Health Blood Pressure Monitor

    Happy Health, Inc.

    K254000 · Substantially Equivalent · Cardiovascular

  • M•care System (MW-20)

    Marani Health, Inc.

    K253673 · Substantially Equivalent · Obstetrics/Gynecology

  • Mayumi™ Thrombectomy System

    MicroVention, Inc., d/b/a Terumo Neuro

    K254035 · Substantially Equivalent · Cardiovascular

Showing 12 of 15. Search the rest in openFDA.

Label changesCovers FDA's Thu, Sep 3 (two weeks ago)
3 touch MedGrid136
  • Komxsum LIDOCAINE CreamTouches MedGrid categories

    Wenzhou Yuyuan Pharmaceutical Co., Ltd.

    Label version 1

  • ZHI TechnologiesTouches MedGrid categories

    ZHI Technologies, Inc.

    Label version 1

  • Lidocaine ViscousTouches MedGrid categories

    REMEDYREPACK INC.

    Label version 5

  • Dollar General

    Dollar General Corporation

    Label version 4

  • DG health Extra Strength Assorted Fruits Antacid

    DOLGENCORP, LLC

    Label version 8

  • ADMELOG

    REMEDYREPACK INC.

    Label version 4

  • Drug label

    Label version 5

  • bupropion hydrochloride

    REMEDYREPACK INC.

    Label version 4

  • DG HEALTH Regular Strength

    DOLGENCORP, LLC

    Label version 3

  • aripiprazole

    Apotex Corp.

    Label version 17

  • Drug label

    Label version 1

  • Etodolac

    REMEDYREPACK INC.

    Label version 4

Showing 12 of 136. 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.