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FDA Daily

FDA daily for Friday, September 4, 2026

188 FDA records across 3 sections. 1 touches MedGrid's categories and is listed first.

188FDA Records
3 of 7Sections With Data
1Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Sep 3 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Fri, Aug 28 (a week ago)
11
  • MEPERIDINE HYDROCHLORIDE

    MEPERIDINE HYDROCHLORIDE — HIKMA

    ANDA040110 · Labeling

  • STELARA

    USTEKINUMAB — JANSSEN BIOTECH

    BLA761044 · Efficacy

  • STELARA

    USTEKINUMAB — CENTOCOR ORTHO BIOTECH INC

    BLA125261 · Labeling

  • CARBIDOPA AND LEVODOPA

    CARBIDOPA, LEVODOPA — APOTEX

    ANDA076212 · Labeling

  • CALCIUM GLUCONATE IN SODIUM CHLORIDE

    CALCIUM GLUCONATE — MILLA PHARMS

    ANDA219037 · Original approval

  • BESREMI

    ROPEGINTERFERON ALFA-2B-NJFT — PHARMAESSENTIA CORP

    BLA761166 · Efficacy

  • YUSIMRY

    ADALIMUMAB-AQVH — EMERGE BIOSCIENCE PTE LTD

    BLA761216 · Labeling

  • MIMRYLO

    RUSFERTIDE ACETATE — TAKEDA PHARMS AM

    NDA220605 · Original approval

  • MEPERIDINE HYDROCHLORIDE

    MEPERIDINE HYDROCHLORIDE — HIKMA

    ANDA088744 · Labeling

  • GADOTERIDOL

    GADOTERIDOL — HAINAN POLY

    ANDA218749 · Labeling

  • HEMANGEOL

    PROPRANOLOL HYDROCHLORIDE — ETON

    NDA205410 · Labeling

Drug recallsCovers FDA's Fri, Aug 28 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Aug 28 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Aug 28 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Aug 21 (two weeks ago)
19
  • Cimilre Dual Max

    Cimilre Co., Ltd.

    K260643 · Substantially Equivalent · Obstetrics/Gynecology

  • Tempus ECG-PH

    Tempus AI, Inc.

    K253699 · Substantially Equivalent · Cardiovascular

  • Solo Scope Colonoscope System

    Gi View, Ltd.

    K261015 · Substantially Equivalent · Gastroenterology, Urology

  • Disposable Warming Blanket

    Hangzhou Tappa Medical Technology Co., Ltd.

    K262089 · Substantially Equivalent · Cardiovascular

  • ReneuRx™ (Neural Ice)

    Brixton Biosciences

    DEN250067 · Unknown · Orthopedic

  • IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

    Immunodiagnostics Systems Limited

    K253817 · Substantially Equivalent · Immunology

  • BoneMRI

    Mriguidance B.V.

    K260584 · Substantially Equivalent · Radiology

  • AVVIGO™+ Multi-Modality Guidance System

    Boston Scientific

    K253692 · Substantially Equivalent · Cardiovascular

  • Pisces-SC Standalone Cervical Interbody System

    Osseus Fusions Systems, LLC

    K261882 · Substantially Equivalent · Orthopedic

  • Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

    Zeus Scientific

    K261466 · Substantially Equivalent · Immunology

  • uAngio AVIVA CX

    Shanghai United Imaging Healthcare Co., Ltd.

    K253726 · Substantially Equivalent · Radiology

  • Affera Integrated Mapping System

    Medtronic, Inc.

    K262005 · Substantially Equivalent · Cardiovascular

Showing 12 of 19. Search the rest in openFDA.

Label changesCovers FDA's Fri, Aug 21 (two weeks ago)
1 touch MedGrid158
  • Lidocaine Numbing CreamTouches MedGrid categories

    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

    Label version 1

  • Medline

    Medline Industries, LP

    Label version 5

  • Metformin Hydrochloride

    REMEDYREPACK INC.

    Label version 15

  • Sodium Acetate

    Amneal Pharmaceuticals Private Limited

    Label version 4

  • Capsaicin 0.035 Percent

    Preferred Pharmaceuticals Inc.

    Label version 1

  • dantrolene sodium

    Par Health USA, LLC

    Label version 7

  • Drug label

    Label version 3

  • atomoxetine

    Northstar Rx LLC

    Label version 7

  • Stay Awake

    United Natural Foods, Inc. dba UNFI

    Label version 18

  • MUSTELA Diaper Rash 1 2 3

    Expanscience Laboratories d/b/a Mustela

    Label version 9

  • COLGATE TOTAL ACTIVE PREVENTION CLEAN MINT

    Colgate-Palmolive Company

    Label version 3

  • LEVETIRACETAM

    REMEDYREPACK INC.

    Label version 1

Showing 12 of 158. 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.