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FDA Daily

FDA daily for Friday, August 14, 2026

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

194FDA Records
4 of 7Sections With Data
4Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Aug 13 (yesterday)
7
  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-96) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-96) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-06) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-06) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-11) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Diclofenac Sodium Tablet, Delayed Release

    Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-11) — Teva Pharmaceuticals USA, Inc.

    New · To Be Discontinued · Musculoskeletal

  • Polyethylene glycol 3350, Sodium Ascorbate, Sodium Sulfate Anhydrous, Ascorbic Acid, Sodium Chloride, and Potassium Chl…

    Plenvu, Oral Solution, KIT (NDC 65649-400-01) — Salix Pharmaceuticals, a division of Bausch Health US, LLC

    New · To Be Discontinued · Gastroenterology

Drug approvalsCovers FDA's Fri, Aug 7 (a week ago)
19
  • FOSAPREPITANT DIMEGLUMINE

    FOSAPREPITANT DIMEGLUMINE — MSN

    ANDA209965 · Labeling

  • FOSAPREPITANT DIMEGLUMINE

    FOSAPREPITANT DIMEGLUMINE — FRESENIUS KABI USA

    ANDA206197 · Labeling

  • RAMIPRIL

    RAMIPRIL — CIPLA

    ANDA077004 · Labeling

  • FOSAPREPITANT DIMEGLUMINE

    FOSAPREPITANT DIMEGLUMINE — BE PHARMS

    ANDA212309 · Labeling

  • RAMIPRIL

    RAMIPRIL — HIKMA

    ANDA077900 · Labeling

  • SODIUM BUTABARBITAL

    BUTABARBITAL SODIUM — HIKMA

    ANDA085418 · Labeling

  • SODIUM BUTABARBITAL

    BUTABARBITAL SODIUM — HIKMA

    ANDA085432 · Labeling

  • SODIUM ZIRCONIUM CYCLOSILICATE

    SODIUM ZIRCONIUM CYCLOSILICATE — LUPIN

    ANDA217549 · Original approval

  • IQIRVO

    ELAFIBRANOR — IPSEN

    NDA218860 · Labeling

  • FLURBIPROFEN

    FLURBIPROFEN — GENUS

    ANDA074431 · Labeling

  • RAMIPRIL

    RAMIPRIL — LUPIN

    ANDA077626 · Labeling

  • FOSAPREPITANT DIMEGLUMINE

    FOSAPREPITANT DIMEGLUMINE — EUGIA PHARMA

    ANDA210625 · Labeling

Showing 12 of 19. Search the rest in openFDA.

Drug recallsCovers FDA's Fri, Aug 7 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Aug 7 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Aug 7 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Jul 31 (two weeks ago)
24
  • Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart…

    Shanghai Hulu Devices Co., Ltd.

    K261494 · Substantially Equivalent · Cardiovascular

  • Flexitouch® Plus Advanced Pneumatic Compression System

    Tactile Medical

    K253555 · Substantially Equivalent · Cardiovascular

  • EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

    Olympus Medical Systems Corporation

    K261183 · Substantially Equivalent · Gastroenterology, Urology

  • Interwedge® Standalone Lateral

    Foundation Surgical Group

    K261809 · Substantially Equivalent · Orthopedic

  • RadioViewAI

    Neurocareai, Inc. (Dba Savelife.Ai)

    K260936 · Substantially Equivalent · Radiology

  • Shield System (Siemens 30x40)

    Radiaction , Ltd.

    K260607 · Substantially Equivalent · Radiology

  • ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

    Globus Medical, Inc.

    K262251 · Substantially Equivalent · Orthopedic

  • NanoCeram Resin

    3BFAB TEKNOLOJI A.S.

    K262681 · Substantially Equivalent · Dental

  • da Vinci Surgical System, Model IS5000

    Intuitive Surgical, Inc.

    K261824 · Substantially Equivalent · Gastroenterology, Urology

  • Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

    Orthalign, Inc.

    K262253 · Substantially Equivalent · Neurology

  • LightStim for Wrinkles (1984); LightStim for Acne (2038)

    Led Intellectual Properties, LLC

    K261482 · Substantially Equivalent · General, Plastic Surgery

  • Angled Screwdriver MED (M-SD090)

    W&H Dentalwerk Bürmoos GmbH

    K253655 · Substantially Equivalent · Dental

Showing 12 of 24. Search the rest in openFDA.

Label changesCovers FDA's Fri, Jul 31 (two weeks ago)
4 touch MedGrid144
  • KEYTRUDA QLEXTouches MedGrid categories

    Merck Sharp & Dohme LLC

    Label version 18

  • LidocaineTouches MedGrid categories

    PHOENIX RX LLC

    Label version 1

  • MinivelleTouches MedGrid categories

    Noven Therapeutics, LLC

    Label version 20

  • MetabatoneTouches MedGrid categories

    Energique, Inc.

    Label version 2

  • Neurostat

    Energique, Inc.

    Label version 7

  • Haloperidol

    REMEDYREPACK INC.

    Label version 9

  • Coreg

    Waylis Therapeutics LLC

    Label version 3

  • Atorvastatin Calcium

    REMEDYREPACK INC.

    Label version 10

  • Joint and Tendon Rescue

    Peaceful Mountain, Inc.

    Label version 2

  • Adapalene Gel

    Acne Free LLC

    Label version 4

  • Adapalene

    Acne Free, LLC

    Label version 4

  • sulfur acne treatment

    Acne Free

    Label version 4

Showing 12 of 144. 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.