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FDA Daily

FDA daily for Thursday, September 10, 2026

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

208FDA Records
4 of 7Sections With Data
6Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Sep 9 (yesterday)
1
  • Imipenem Anhydrous, Cilastatin, and Relebactam Anhydrous Injection

    RECARBRIO, Injection, 500 mg/100 mL; 500 mg/100 mL; 250 mg/100 mL (NDC 0006-3856-02) — Merck Sharp & Dohme LLC

    New · To Be Discontinued · Anti-Infective

Drug approvalsCovers FDA's Thu, Sep 3 (a week ago)
1 touch MedGrid7
  • TESTOSTERONE CYPIONATETouches MedGrid categories

    TESTOSTERONE CYPIONATE — BPI LABS

    ANDA219478 · Original approval

  • ACYCLOVIR

    ACYCLOVIR — CADILA PHARMS LTD

    ANDA202168 · Labeling

  • ZANVASTRO

    ZILGANERSEN SODIUM — IONIS PHARMS INC

    NDA220210 · Original approval

  • UPLIZNA

    INEBILIZUMAB-CDON — VIELA BIO

    BLA761142 · Labeling

  • MODAFINIL

    MODAFINIL — LUPIN

    ANDA208343 · Original approval

  • OMCAZIO

    CABOZANTINIB LAURYLSULFATE — HANDA ONCOL

    NDA220613 · Original approval

  • TAPENTADOL HYDROCHLORIDE

    TAPENTADOL HYDROCHLORIDE — MSN

    ANDA220865 · Original approval

Drug recallsCovers FDA's Thu, Sep 3 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Sep 3 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Sep 3 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Aug 27 (two weeks ago)
1 touch MedGrid17
  • 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Touches MedGrid categories

    Zhengzhou PZ Laser Slim Technology Co., Ltd.

    K261821 · Substantially Equivalent · General, Plastic Surgery

  • EasyCare Tx 2

    Resmed Corp

    K261360 · Substantially Equivalent · Anesthesiology

  • Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

    Gebauer Company

    K260870 · Substantially Equivalent · Unknown

  • 35 Helix Guidewire

    Piraeus Medical, Inc.

    K260751 · Substantially Equivalent · Cardiovascular

  • CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ON…

    Ascensia Diabetes Care

    K260545 · Substantially Equivalent · Clinical Chemistry

  • Dexus Prosthetic System (MSL2, MSR2)

    Zhejiang Qiangnao Technology Co.,Ltd

    K262654 · Substantially Equivalent · Neurology

  • Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Mat…

    Berkeley Advanced Biomaterials

    K260711 · Substantially Equivalent · Unknown

  • Iconix Knotless T

    Riverpoint Medical

    K262677 · Substantially Equivalent · Orthopedic

  • Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

    Ram.Shaw Pte., Ltd.

    K262104 · Substantially Equivalent · Dental

  • Optiflow Oxygen Kit (AA484J)

    Fisher and Paykel Healthcare Limited

    K262268 · Substantially Equivalent · Anesthesiology

  • Glidewell™ Denture Base Resin

    Prismatik Dentalcraft, Inc.

    K261802 · Substantially Equivalent · Dental

  • GenesisX RMN

    Stereotaxis, Inc.

    K262744 · Substantially Equivalent · Cardiovascular

Showing 12 of 17. Search the rest in openFDA.

Label changesCovers FDA's Thu, Aug 27 (two weeks ago)
4 touch MedGrid183
  • XylocaineTouches MedGrid categories

    REMEDYREPACK INC.

    Label version 6

  • ISNTREE HYALURONIC ACID DAILY SUNGELTouches MedGrid categories

    ISNTREE Inc.

    Label version 1

  • MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50Touches MedGrid categories

    Guangzhou Meixi Biotechnology Co., Ltd.

    Label version 1

  • 4% Lidocaine PatchesTouches MedGrid categories

    Shenzhen Chaoxiji Technology Co.,Ltd.

    Label version 1

  • Glipizide

    Bryant Ranch Prepack

    Label version 102

  • Losartan Potassium

    Cardinal Health 107, LLC

    Label version 21

  • Mix-In Laxative Packets

    Wal-Mart Stores Inc

    Label version 10

  • Methocarbamol

    Cardinal Health 107, LLC

    Label version 6

  • BIXLENVO

    Gilead Sciences, Inc.

    Label version 1

  • Vardenafil Hydrochloride

    Bryant Ranch Prepack

    Label version 103

  • Drug label

    Label version 102

  • Bupropion hydrochloride

    REMEDYREPACK INC.

    Label version 4

Showing 12 of 183. 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.