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FDA Daily

FDA daily for Tuesday, August 25, 2026

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

200FDA Records
4 of 7Sections With Data
4Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Aug 24 (yesterday)
7
  • Dextrose Monohydrate 50% Injection

    Dextrose Monohydrate 50%, Injection, 25 g/50 mL (NDC 0409-6648-02) — Hospira, Inc., a Pfizer Company

    Revised · Current · Endocrinology/Metabolism

  • Disopyramide Phosphate Capsule, Extended Release

    Norpace CR, Capsule, Extended Release, 100 mg (NDC 0025-2732-31) — Pfizer Inc.

    New · To Be Discontinued · Cardiovascular

  • Disopyramide Phosphate Capsule, Extended Release

    Norpace CR, Capsule, Extended Release, 150 mg (NDC 0025-2742-31) — Pfizer Inc.

    New · To Be Discontinued · Cardiovascular

  • Sodium Acetate Injection

    Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-06) — Hospira, Inc., a Pfizer Company

    Reverified · Current · Endocrinology/Metabolism

  • Atropine Sulfate Injection

    Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-1630-10) — Hospira, Inc., a Pfizer Company

    Revised · Current · Anesthesia

  • Etomidate Injection

    Amidate, Injection, 2 mg/mL (NDC 0409-6695-02) — Hospira, Inc., a Pfizer Company

    Reverified · Current · Anesthesia

  • Dexmedetomidine Hydrochloride Injection

    Precedex, Injection, 400 mcg/100 mL (4 mcg/mL) (NDC 0409-1596-10) — Pfizer Inc.

    Reverified · Current · Anesthesia

Drug approvalsCovers FDA's Tue, Aug 18 (a week ago)
1 touch MedGrid8
  • LIDOCAINE HYDROCHLORIDETouches MedGrid categories

    LIDOCAINE HYDROCHLORIDE — PAI HOLDINGS PHARM

    ANDA204494 · Labeling

  • NALOXONE HYDROCHLORIDE

    NALOXONE HYDROCHLORIDE — STERINOVA INC

    ANDA219942 · Original approval

  • LEROCHOL

    LERODALCIBEP-LIGA — LIB THERAPEUTICS, INC.

    BLA761427 · Labeling

  • TYZAVAN

    VANCOMYCIN HYDROCHLORIDE — HIKMA

    NDA211962 · Labeling

  • BARACLUDE

    ENTECAVIR — BRISTOL MYERS SQUIBB

    NDA021798 · Labeling

  • BARACLUDE

    ENTECAVIR — BRISTOL MYERS SQUIBB

    NDA021797 · Labeling

  • FLUTICASONE PROPIONATE

    FLUTICASONE PROPIONATE — GLENMARK SPECLT

    ANDA219232 · Original approval

  • POLYETHYLENE GLYCOL 3350

    POLYETHYLENE GLYCOL 3350 — PPI-DAC

    ANDA090685 · Manufacturing (CMC)

Drug recallsCovers FDA's Tue, Aug 18 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Aug 18 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Aug 18 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Aug 11 (two weeks ago)
1 touch MedGrid6
  • Q Switched Nd:YAG Laser machine (QLQW-01)Touches MedGrid categories

    Beijing Nubway S&T Co., Ltd.

    K261841 · Substantially Equivalent · General, Plastic Surgery

  • VR® Personal Protective Level 4 Gown (VR Gowns)

    PolyConversions, Inc.

    K261115 · Substantially Equivalent · General, Plastic Surgery

  • Dexter L6 System

    Distalmotion SA

    K261398 · Substantially Equivalent · General, Plastic Surgery

  • INNOVANCE® D-Dimer 2.0 (SMN 10873803)

    Siemens Healthcare Diagnostic Products GmbH

    K253985 · Substantially Equivalent · Hematology

  • Vashe Plus Antimicrobial Solution

    Urgo Medical North America, LLC

    K253665 · Substantially Equivalent · Unknown

  • Stelo Glucose Biosensor System

    Dexcom, Inc.

    K262472 · Substantially Equivalent · Clinical Chemistry

Label changesCovers FDA's Tue, Aug 11 (two weeks ago)
2 touch MedGrid179
  • Stay Ageless Tinted Mineral SunscreenTouches MedGrid categories

    DR. SAMRAO'S OFFICE

    Label version 2

  • ESTRADIOL VAGINALTouches MedGrid categories

    Redpharm Drug

    Label version 1

  • Drug label

    Label version 106

  • Benzonatate

    Bryant Ranch Prepack

    Label version 1

  • Ciele Tint and Protect

    Ciele

    Label version 5

  • Tetracycline Hydrochloride

    Bryant Ranch Prepack

    Label version 1

  • NINLARO

    Takeda Pharmaceuticals America, Inc.

    Label version 18

  • Hydrocortisone

    Solco Healthcare LLC

    Label version 1

  • Paroxetine

    REMEDYREPACK INC.

    Label version 9

  • Divalproex sodium

    Cardinal Health 107, LLC

    Label version 8

  • Medline

    Medline Industries, LP

    Label version 4

  • Aller-Chord A

    Energetix Corporation

    Label version 12

Showing 12 of 179. 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.