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FDA Daily

FDA daily for Monday, October 5, 2026

30 FDA records across 3 sections.

30FDA Records
3 of 7Sections With Data
0Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Sun, Oct 4 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Mon, Sep 28 (a week ago)
16
  • EMCITATE

    TIRATRICOL — RARE THYROID

    NDA220963 · Original approval

  • TRANEXAMIC ACID

    TRANEXAMIC ACID — AVET LIFESCIENCES

    ANDA203521 · Labeling

  • LABETALOL HYDROCHLORIDE

    LABETALOL HYDROCHLORIDE — AMNEAL

    ANDA218870 · Labeling

  • MINOCYCLINE HYDROCHLORIDE

    MINOCYCLINE HYDROCHLORIDE — AUROBINDO PHARMA

    ANDA065470 · Labeling

  • METHYLPHENIDATE HYDROCHLORIDE

    METHYLPHENIDATE HYDROCHLORIDE — GRANULES

    ANDA213473 · Labeling

  • METHYLPHENIDATE HYDROCHLORIDE

    METHYLPHENIDATE HYDROCHLORIDE — SUN PHARM INDS INC

    ANDA217229 · Labeling

  • RUXIENCE

    RITUXIMAB-PVVR — PFIZER INC

    BLA761103 · SUPPL

  • PREDNISOLONE ACETATE

    PREDNISOLONE ACETATE — UPSHER SMITH LABS

    ANDA212778 · Original approval

  • DEXMETHYLPHENIDATE HYDROCHLORIDE

    DEXMETHYLPHENIDATE HYDROCHLORIDE — TEVA PHARMS

    ANDA077107 · Labeling

  • METHYLPHENIDATE HYDROCHLORIDE

    METHYLPHENIDATE HYDROCHLORIDE — ACCORD HLTHCARE

    ANDA213936 · Labeling

  • POLYETHYLENE GLYCOL 3350

    POLYETHYLENE GLYCOL 3350 — AUROBINDO PHARMA LTD

    ANDA209017 · Manufacturing (CMC)

  • CHILDREN'S ZYRTEC ALLERGY

    CETIRIZINE HYDROCHLORIDE — KENVUE BRANDS

    NDA021621 · Manufacturing (CMC)

Showing 12 of 16. Search the rest in openFDA.

Drug recallsCovers FDA's Mon, Sep 28 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Mon, Sep 28 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Mon, Sep 28 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Mon, Sep 21 (two weeks ago)
11
  • F.A.S.T Screw

    Steps Ortho

    K254280 · Substantially Equivalent · Orthopedic

  • KARL STORZ TIPCAM1 Rubina

    KALR STORZ SE & Co. KG

    K262547 · Substantially Equivalent · Gastroenterology, Urology

  • Rapid Platform (R6.7)

    Ischemaview, Inc.

    K261368 · Substantially Equivalent · Radiology

  • OtoCompanion (Version 1.0)

    Ironsides Medical, Inc.

    K261725 · Substantially Equivalent · Ear, Nose, Throat

  • TriSalus TriNav Advance Infusion System

    Trisalus Life Sciences

    K253509 · Substantially Equivalent · Cardiovascular

  • ZYLOX Hippo PTA Balloon Dilatation Catheter

    Zylox Medtech Co., Ltd.

    K260416 · Substantially Equivalent · Cardiovascular

  • Access NT-proBNP

    Beckman Coulter, Inc.

    K262109 · Substantially Equivalent · Clinical Chemistry

  • BellaTek Bars

    ZimVie US Corp, LLC

    K260940 · Substantially Equivalent · Dental

  • Disposable Ureteral Access Sheath

    Yangzhou Fartley Medical Instrument Technology Co., Ltd.

    K260512 · Substantially Equivalent · Gastroenterology, Urology

  • FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male…

    Shanghai Personage Hygiene Products Co., Ltd.

    K262108 · Substantially Equivalent · Obstetrics/Gynecology

  • Core·it Dual

    Spident Co., Ltd.

    K262982 · Substantially Equivalent · Dental

Label changesCovers FDA's Mon, Sep 21 (two weeks ago)
3
  • Varenicline

    A-S Medication Solutions

    Label version 1

  • Gillette ClearShield Sport Active Clear

    The Procter & Gamble Manufacturing Company

    Label version 1

  • Varenicline

    REMEDYREPACK INC.

    Label version 3

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.