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FDA Daily

FDA daily for Monday, August 17, 2026

142 FDA records across 3 sections. 6 touch MedGrid's categories and are listed first.

142FDA Records
3 of 7Sections With Data
6Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Sun, Aug 16 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Mon, Aug 10 (a week ago)
9
  • DIGOXIN

    DIGOXIN — SANDOZ

    ANDA040481 · Labeling

  • OLANZAPINE

    OLANZAPINE — DR REDDYS LABS LTD

    ANDA076255 · Labeling

  • BRIVARACETAM

    BRIVARACETAM — AUROBINDO PHARMA

    ANDA220288 · Original approval

  • MEROPENEM

    MEROPENEM — HQ SPCLT PHARMA

    NDA215212 · Labeling

  • METFORMIN HYDROCHLORIDE

    METFORMIN HYDROCHLORIDE — BARR

    ANDA076863 · Labeling

  • SCOPOLAMINE

    SCOPOLAMINE — MYLAN TECHNOLOGIES

    ANDA203753 · Labeling

  • OLANZAPINE

    OLANZAPINE — DR REDDYS LABS LTD

    ANDA076133 · Labeling

  • DALFAMPRIDINE

    DALFAMPRIDINE — MICRO LABS

    ANDA210158 · Manufacturing (CMC)

  • GADOTERATE MEGLUMINE

    GADOTERATE MEGLUMINE — VIWIT PHARM

    ANDA219286 · Original approval

Drug recallsCovers FDA's Mon, Aug 10 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Mon, Aug 10 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Mon, Aug 10 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Mon, Aug 3 (two weeks ago)
8
  • PuraStat GI

    3-D Matrix, Inc.

    K261503 · Substantially Equivalent · General, Plastic Surgery

  • Eve

    Wandercraft SAS

    K260381 · Substantially Equivalent · Physical Medicine

  • Grappler Suture Anchor System

    Paragon 28, Inc.

    K262047 · Substantially Equivalent · Orthopedic

  • Halcyon, Ethos Radiotherapy System (5.0)

    Varian Medical Systems, Inc.

    K261856 · Substantially Equivalent · Radiology

  • PuraStat-RM

    3-D Matrix, Inc.

    K261504 · Substantially Equivalent · Unknown

  • SABER-XA System

    Elevation Spine

    K261408 · Substantially Equivalent · Orthopedic

  • XLITE

    GEMSS HEALTHCARE CO., LTD.

    K260236 · Substantially Equivalent · Radiology

  • VueJect® Ultrasound Enhancing Agent Delivery System

    ACIST Medical Systems, Inc.

    K262115 · Substantially Equivalent · Cardiovascular

Label changesCovers FDA's Mon, Aug 3 (two weeks ago)
6 touch MedGrid125
  • EltaMD UV ActiveTouches MedGrid categories

    CP Skin Health Group, Inc

    Label version 1

  • Lidocaine HydrochlorideTouches MedGrid categories

    Medical Purchasing Solutions, LLC

    Label version 2

  • Lidocaine Numbing CreamTouches MedGrid categories

    Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.

    Label version 2

  • Pain Relief Knee Gel-PatchTouches MedGrid categories

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

    Label version 1

  • Lidocaine HydrochlorideTouches MedGrid categories

    YYBA CORP

    Label version 1

  • Manyo Air Light Moisturizing Sunscreen SPF 50Touches MedGrid categories

    Manyo Factory Corp.

    Label version 3

  • equaline nighttime cold and flu relief

    United Natural Foods, Inc. dba UNFI

    Label version 11

  • Drug label

    Label version 15

  • Maximum Strength Antifungal Liquid

    Meijer Distribution Inc

    Label version 5

  • MUCINEX INSTASOOTHE COUGH

    Reckitt Benckiser LLC

    Label version 5

  • Pregabalin

    REMEDYREPACK INC.

    Label version 1

  • Ceftazidime

    Sagent Pharmaceuticals

    Label version 12

Showing 12 of 125. 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.