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FDA Daily

FDA daily for Thursday, October 1, 2026

61 FDA records across 4 sections. 1 touches MedGrid's categories and is listed first.

61FDA Records
4 of 7Sections With Data
1Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Sep 30 (yesterday)
15
  • Bumetanide Injection

    Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-10) — Sagent Pharmaceuticals

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-102-07) — MSN Laboratories Private Limited

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6007-10) — Hikma Pharmaceuticals USA, Inc.

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, .25 mg/1 mL (NDC 65219-570-04) — Fresenius Kabi USA, LLC

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, 0.25 mg/mL, 10 mL (NDC 72205-102-01) — MSN Laboratories Private Limited

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, 1 mg/4 mL (0.25 mg/mL) (NDC 83301-0080-2) — Mullan Pharmaceutical Inc.

    Revised · Resolved · Cardiovascular

  • Cromolyn Sodium Concentrate

    Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 69784-200-96) — Ailex Pharmaceuticals

    Reverified · Current · Pulmonary/Allergy

  • Bumetanide Injection

    Bumetanide, Injection, 0.25 mg/mL, 4mL (NDC 72205-101-01) — MSN Laboratories Private Limited

    Revised · Resolved · Cardiovascular

  • Cromolyn Sodium Concentrate

    Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96) — Ailex Pharmaceuticals

    Reverified · Current · Pulmonary/Allergy

  • Bumetanide Injection

    Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6008-10) — Hikma Pharmaceuticals USA, Inc.

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, .25 mg/1 mL (NDC 65219-572-10) — Fresenius Kabi USA, LLC

    Revised · Resolved · Cardiovascular

  • Bumetanide Injection

    Bumetanide, Injection, 2.5 mg/10 mL (0.25 mg/mL) (NDC 83301-0081-2) — Mullan Pharmaceutical Inc.

    Revised · Resolved · Cardiovascular

Showing 12 of 15. Search the rest in openFDA.

Drug approvalsCovers FDA's Thu, Sep 24 (a week ago)
17
  • LINACLOTIDE

    LINACLOTIDE — ACTAVIS LABS FL

    ANDA211255 · Original approval

  • RISPERIDONE

    RISPERIDONE — ANI PHARMS

    ANDA076440 · Labeling

  • VALIUM

    DIAZEPAM — WAYLIS THERAP

    NDA013263 · Labeling

  • IDARUBICIN HYDROCHLORIDE

    IDARUBICIN HYDROCHLORIDE — RISING

    ANDA200144 · Labeling

  • DOXYCYCLINE HYCLATE

    DOXYCYCLINE HYCLATE — CHANGZHOU PHARM

    ANDA209402 · Labeling

  • ATOVAQUONE

    ATOVAQUONE — AMNEAL PHARMS

    ANDA202960 · Labeling

  • ARSENIC TRIOXIDE

    ARSENIC TRIOXIDE — NEXUS

    ANDA209780 · Labeling

  • PHENYLEPHRINE HYDROCHLORIDE

    PHENYLEPHRINE HYDROCHLORIDE — NEPHRON

    ANDA215268 · Original approval

  • BUTORPHANOL TARTRATE PRESERVATIVE FREE

    BUTORPHANOL TARTRATE — HOSPIRA

    ANDA074626 · Labeling

  • DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

    DAPTOMYCIN — BAXTER HLTHCARE CORP

    NDA213645 · Labeling

  • ATOVAQUONE

    ATOVAQUONE — BIONPHARMA

    ANDA212918 · Labeling

  • LENVIMA

    LENVATINIB MESYLATE — EISAI INC

    NDA206947 · Efficacy

Showing 12 of 17. Search the rest in openFDA.

Drug recallsCovers FDA's Thu, Sep 24 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Sep 24 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Sep 24 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Sep 17 (two weeks ago)
1 touch MedGrid18
  • Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Touches MedGrid categories

    Zhengzhou PZ Laser Slim Technology Co., Ltd.

    K261817 · Substantially Equivalent · General, Plastic Surgery

  • Wearable Breast Pump (Model S36)

    Shenzhen TPH Technology Co., Ltd.

    K254203 · Substantially Equivalent · Obstetrics/Gynecology

  • FRAXION Spinal Fixation System

    Ortler Global Tibbi Gerecler Anonim Sirketi

    K262091 · Substantially Equivalent · Orthopedic

  • Hygienic Protective Bite Cover (2207-010-50)

    Dürr Dental SE

    K262073 · Substantially Equivalent · General, Plastic Surgery

  • Durashield Device Kit

    SurGenTec, LLC

    K252995 · Substantially Equivalent · Neurology

  • Miru 1day UpSide (midafilcon A)

    Menicon Co, Ltd.

    K262495 · Substantially Equivalent · Ophthalmic

  • MOWANA™ Auto Duo

    PENTAMASTER MEDIQ SDN BHD

    K261266 · Substantially Equivalent · General Hospital

  • LED Therapy Device (QLXY-01)

    Beijing Nubway S&T Co., Ltd.

    K261673 · Substantially Equivalent · General, Plastic Surgery

  • M-Vizion Femoral Revision System Extension

    Medacta International S.A.

    K260173 · Substantially Equivalent · Orthopedic

  • Protégé™ EverFlex™ Self-expanding Peripheral Stent System

    Medtronic, Inc.

    K262913 · Substantially Equivalent · Gastroenterology, Urology

  • TriActive Dental Implant System

    Paragon Implant Mfg., LLC

    K261392 · Substantially Equivalent · Dental

  • Integrity Retractable Implant Inserter (6000127)

    Anika Therapeutics, Inc.

    K261869 · Substantially Equivalent · Orthopedic

Showing 12 of 18. Search the rest in openFDA.

Label changesCovers FDA's Thu, Sep 17 (two weeks ago)
11
  • Drug label

    Label version 4

  • Drug label

    Label version 9

  • Lymph Tonic II

    BioActive Nutritional, Inc.

    Label version 2

  • Drug label

    Label version 11

  • COLTALIN-DM

    FORTUNE PHARMACAL COMPANY LIMITED

    Label version 4

  • Drug label

    Label version 6

  • hand sanitizer chocolate chip cookie scent

    Diamond Life Cosmetics Trading FZCO

    Label version 1

  • Dramamine Orange

    Medtech Products Inc.

    Label version 7

  • COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT

    Colgate-Palmolive Company

    Label version 1

  • Drug label

    Label version 3

  • Drug label

    Label version 7

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.