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FDA Daily

FDA daily for Friday, August 21, 2026

229 FDA records across 4 sections. 2 touch MedGrid's categories and are listed first.

229FDA Records
4 of 7Sections With Data
2Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Thu, Aug 20 (yesterday)
13
  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0406-8894-01) — SpecGx LLC

    Revised · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0406-8885-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 0406-8884-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 0406-8892-01) — SpecGx LLC

    Revised · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0406-8891-01) — SpecGx LLC

    Revised · Current · Psychiatry

  • Lisdexamfetamine Dimesylate Capsule

    Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01) — SpecGx LLC

    Reverified · Current · Psychiatry

  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

    Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0406-8893-01) — SpecGx LLC

    Reverified · Current · Psychiatry

Showing 12 of 13. Search the rest in openFDA.

Drug approvalsCovers FDA's Fri, Aug 14 (a week ago)
40
  • BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — SPECGX LLC

    ANDA207000 · REMS

  • PITOLISANT HYDROCHLORIDE

    PITOLISANT HYDROCHLORIDE — LUPIN

    ANDA218846 · Original approval

  • BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — AMNEAL PHARMS

    ANDA203136 · REMS

  • BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — LANNETT CO INC

    ANDA205022 · REMS

  • YESINTEK

    USTEKINUMAB-KFCE — BIOCON BIOLOGICS INC

    BLA761406 · Efficacy

  • PITOLISANT HYDROCHLORIDE

    PITOLISANT HYDROCHLORIDE — MSN

    ANDA218873 · Original approval

  • BUPRENORPHINE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE — ASCENT PHARMS INC

    ANDA219401 · REMS

  • BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — ACTAVIS ELIZABETH

    ANDA091422 · REMS

  • BUPRENORPHINE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE — SPECGX LLC

    ANDA218473 · REMS

  • PROPRANOLOL HYDROCHLORIDE

    PROPRANOLOL HYDROCHLORIDE — CREEKWOOD PHARMS

    ANDA219460 · Original approval

  • SUBOXONE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — INDIVIOR

    NDA022410 · REMS

  • BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

    BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE — TEVA PHARMS USA

    ANDA091149 · REMS

Showing 12 of 40. Search the rest in openFDA.

Drug recallsCovers FDA's Fri, Aug 14 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Fri, Aug 14 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Fri, Aug 14 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Fri, Aug 7 (two weeks ago)
19
  • PacTemp Automix NE

    The Belport Company Inc., DBA Gingi-Pak

    K261937 · Substantially Equivalent · Dental

  • Venue Go

    GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

    K261668 · Substantially Equivalent · Radiology

  • Aperio GT 450 DX; Aperio GT 180 DX

    Leica Biosystems Imaging, Inc.

    K253554 · Substantially Equivalent · Pathology

  • Zamenix™ P

    Roen Surgical, Inc.

    K253505 · Substantially Equivalent · Gastroenterology, Urology

  • Zenition 30

    Philips Medical Systems Nederland B.V.

    K254205 · Substantially Equivalent · Radiology

  • Xpert Hemorrhagic Fever

    Cepheid

    K261362 · Substantially Equivalent · Immunology

  • Intuitive Endoluminal Gastrointestinal System (IG1000)

    Intuitive Surgical, Inc.

    K253702 · Substantially Equivalent · Gastroenterology, Urology

  • Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S205…

    Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

    K260933 · Substantially Equivalent · General Hospital

  • BUM Oil

    Bumlicious, LLC (DBA “Bumlicious”)

    K261905 · Substantially Equivalent · Obstetrics/Gynecology

  • LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

    Shenzhen Chuangtong Yigou Technology Co., Ltd.

    K261601 · Substantially Equivalent · General, Plastic Surgery

  • Mistral-Air® Warming System

    The Surgical Company International B.V., doing business as TSC Life

    K261437 · Substantially Equivalent · Cardiovascular

  • Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

    Lakong Medical Devices Co., Ltd.

    K251544 · Substantially Equivalent · Dental

Showing 12 of 19. Search the rest in openFDA.

Label changesCovers FDA's Fri, Aug 7 (two weeks ago)
2 touch MedGrid157
  • LidonexTouches MedGrid categories

    Aldama Pharmaceuticals, Inc

    Label version 4

  • VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTouches MedGrid categories

    LCM TECHNOLOGY Co., Ltd

    Label version 2

  • Clobetasol Propionate

    Bryant Ranch Prepack

    Label version 109

  • Cetirizine HCl

    GLENMARK THERAPEUTICS INC., USA

    Label version 7

  • OSELTAMIVIR PHOSPHATE

    Aurobindo Pharma Limited

    Label version 3

  • Drug label

    Label version 4

  • Senna S

    Shield Pharmaceuticals Corp

    Label version 3

  • DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU

    Walgreen Company

    Label version 3

  • Atenolol

    Cardinal Health 107, LLC

    Label version 23

  • ABRILADA

    A-S Medication Solutions

    Label version 1

  • tofacitinib

    Zydus Pharmaceuticals USA Inc.

    Label version 7

  • WinCo FOODS Antacid Ultra Strength

    WINCO FOODS, LLC

    Label version 7

Showing 12 of 157. 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.