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FDA Daily

FDA daily for Tuesday, September 22, 2026

239 FDA records across 4 sections. 13 touch MedGrid's categories and are listed first.

239FDA Records
4 of 7Sections With Data
13Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Sep 21 (yesterday)
31
  • Penicillin G Benzathine Injection

    Bicillin L-A, Injection, 1200000 [iU]/2 mL (NDC 60793-701-10) — Pfizer Inc.

    Revised · Current · Anti-Infective

  • Methylprednisolone Acetate Injection

    Depo-medrol, Injection, 40 mg/1 mL (NDC 0009-3073-03) — Pfizer Inc.

    Revised · Current · Rheumatology

  • Clindamycin Phosphate Injection

    Cleocin Phosphate, Injection, Cleocin Phosphate 900 mg/6 mL (150 mg/mL) (NDC 0009-0902-18) — Pfizer Inc.

    Revised · Current · Anti-Infective

  • Dexmedetomidine Hydrochloride Injection

    Precedex, Injection, 1000 mcg/250 mL (NDC 0409-7875-12) — Pfizer Inc.

    Reverified · Current · Anesthesia

  • Penicillin G Benzathine Injection

    Bicillin L-A, Injection, 2400000 [iU]/4 mL (NDC 60793-702-10) — Pfizer Inc.

    Revised · Current · Anti-Infective

  • Methylprednisolone Acetate Injection

    Depo-medrol, Injection, 80 mg/1 mL (NDC 0009-3475-01) — Pfizer Inc.

    Revised · Current · Rheumatology

  • Penicillin G Benzathine Injection

    Bicillin L-A, Injection, 600000 [iU]/1 mL (NDC 60793-700-10) — Pfizer Inc.

    Revised · Current · Anti-Infective

  • Methylprednisolone Acetate Injection

    Depo-medrol, Injection, 40 mg/1 mL (NDC 0009-0280-02) — Pfizer Inc.

    Reverified · Current · Rheumatology

  • Dexmedetomidine Hydrochloride Injection

    Precedex, Injection, 1000 mcg/250 mL Glass Bottle NovaPlus (NDC 0409-2815-01) — Pfizer Inc.

    Reverified · Current · Anesthesia

  • Methylprednisolone Acetate Injection

    Depo-medrol, Injection, 80 mg/1 mL (NDC 0009-3475-03) — Pfizer Inc.

    Revised · Current · Rheumatology

  • Dexmedetomidine Hydrochloride Injection

    Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1660-50) — Pfizer Inc.

    Reverified · Current · Anesthesia

  • Dexmedetomidine Hydrochloride Injection

    Precedex, Injection, 200 mcg/50 mL (4 mcg/mL) (NDC 0409-1454-20) — Pfizer Inc.

    Reverified · Current · Anesthesia

Showing 12 of 31. Search the rest in openFDA.

Drug approvalsCovers FDA's Tue, Sep 15 (a week ago)
2 touch MedGrid15
  • TESTOSTERONETouches MedGrid categories

    TESTOSTERONE — TWI PHARMS

    ANDA209390 · Labeling

  • KETAMINE HYDROCHLORIDETouches MedGrid categories

    KETAMINE HYDROCHLORIDE — EUGIA PHARMA

    ANDA076092 · Labeling

  • AMNESTEEM

    ISOTRETINOIN — MYLAN PHARMS INC

    ANDA075945 · Labeling

  • MILNACIPRAN HYDROCHLORIDE

    MILNACIPRAN HYDROCHLORIDE — MACLEODS PHARMS

    ANDA210944 · Original approval

  • MILNACIPRAN HYDROCHLORIDE

    MILNACIPRAN HYDROCHLORIDE — STRIDES PHARMA

    ANDA207399 · Original approval

  • GARZULYS

    INSULIN ASPART-FSAN — EMERGE BIOSCIENCE PTE. LTD.

    BLA761497 · Original approval

  • DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

    AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE — SUN PHARM INDUSTRIES

    ANDA211715 · Labeling

  • CARBAMAZEPINE

    CARBAMAZEPINE — TEVA PHARMS

    ANDA078592 · Labeling

  • TRETINOIN

    TRETINOIN — ZYDUS LIFESCIENCES

    ANDA218560 · Original approval

  • JYNARQUE

    TOLVAPTAN — OTSUKA

    NDA204441 · Labeling

  • PRAMIPEXOLE DIHYDROCHLORIDE

    PRAMIPEXOLE DIHYDROCHLORIDE — CHARTWELL RX

    ANDA090241 · Labeling

  • TIGECYCLINE

    TIGECYCLINE — MEITHEAL

    ANDA214020 · Labeling

Showing 12 of 15. Search the rest in openFDA.

Drug recallsCovers FDA's Tue, Sep 15 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Sep 15 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Sep 15 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Sep 8 (two weeks ago)
14
  • LiteSet Trays

    Nobel Biocare AB

    K253988 · Substantially Equivalent · General Hospital

  • Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT…

    Zhejiang Geyi Medical Instrument Co., Ltd.

    K254294 · Substantially Equivalent · Obstetrics/Gynecology

  • Dental Barriers and Sleeves (AB0006)

    ANI Co., Ltd.

    K261956 · Substantially Equivalent · General, Plastic Surgery

  • Reusable SmartPeg

    Osstell AB

    K261987 · Substantially Equivalent · Dental

  • Emboliner Embolic Protection System (EPC-03)

    Emboline, Inc.

    K261715 · Substantially Equivalent · Cardiovascular

  • Power Wheelchair (OS-R-M01I)

    Beijing OrionStar Technology Co., Ltd.

    K260053 · Substantially Equivalent · Physical Medicine

  • Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistanc…

    Gmp Medicare Sdn. Bhd.

    K260312 · Substantially Equivalent · General Hospital

  • da Vinci Surgical System, Model IS5000

    Intuitive Surgical, Inc.

    K261823 · Substantially Equivalent · Gastroenterology, Urology

  • Electric wheelchair (HC819N, HC830N, HC831N)

    Yongkang Hengyi Vehicle Co., Ltd.

    K260229 · Substantially Equivalent · Physical Medicine

  • LANDMARK Total Knee System

    Smith & Nephew, Inc.

    K261462 · Substantially Equivalent · Orthopedic

  • EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H

    DRTECH Corporation

    K260227 · Substantially Equivalent · Radiology

  • N22 Offset Humeral Head

    Shoulder Innovations, Inc.

    K262173 · Substantially Equivalent · Orthopedic

Showing 12 of 14. Search the rest in openFDA.

Label changesCovers FDA's Tue, Sep 8 (two weeks ago)
11 touch MedGrid179
  • Intense Therapy Lip Balm Pineapple MintTouches MedGrid categories

    Jack Black, LLC

    Label version 6

  • Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryTouches MedGrid categories

    Jack Black, LLC

    Label version 9

  • Intense Therapy Lip Balm Basil LemonTouches MedGrid categories

    Jack Black, LLC

    Label version 3

  • Jack Black Sun Guard Sunscreen SPF45Touches MedGrid categories

    Jack Black, LLC

    Label version 5

  • Jack Black Intensive Therapy Lip Balm Mango Chili LimeTouches MedGrid categories

    Jack Black, LLC

    Label version 3

  • Baloom 2% Panthenol Hydro Airy SunscreenTouches MedGrid categories

    ARSN KOREA

    Label version 4

  • Jack Black Intense Therapy Lip Balm Vanilla BourbonTouches MedGrid categories

    Jack Black, LLC

    Label version 3

  • Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterTouches MedGrid categories

    Jack Black, LLC

    Label version 9

  • SPF30 Sunscreen 01Touches MedGrid categories

    Cosmuses Cosmetics (Ningbo) Co., Ltd.

    Label version 1

  • Intense Therapy Lip Balm Cucumber LimeTouches MedGrid categories

    Jack Black, LLC

    Label version 3

  • Double-Duty Face MoisturizerTouches MedGrid categories

    Jack Black, LLC

    Label version 9

  • Prednisone

    Bryant Ranch Prepack

    Label version 106

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.