FDA daily for Tuesday, August 4, 2026
In this issue: 1 shortage update, 23 approvals, 2 device recalls, 31 device decisions and 207 label changes. 1 item touches categories MedGrid carries, and it comes first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc. · General Hospital
Drug shortages
FDA date:FDA updated 1 shortage entry on Mon, Aug 3: 1 new, 1 to be discontinued.
Drug and biologic approvals
FDA date:On Tue, Jul 28 FDA approved 19 new applications (1 brand or biologic, 18 generic) and 4 supplements to existing ones.
- SUGAMMADEX SODIUM
GLAND · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
MSN · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
TAMARANG · SUGAMMADEX SODIUM
- GLYCEROL PHENYLBUTYRATE
PAI HOLDINGS · GLYCEROL PHENYLBUTYRATE
- SUGAMMADEX SODIUM
HIKMA · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
HIKMA · SUGAMMADEX SODIUM
- DIAZEPAM
BAXTER HLTHCARE CORP · DIAZEPAM
- SUGAMMADEX SODIUM
TEVA PHARMS USA INC · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
STERISCIENCE · SUGAMMADEX SODIUM
- GWYN LO
VIATRIS SPECIALTY · ETHINYL ESTRADIOL, NORELGESTROMIN
- SUGAMMADEX SODIUM
MANKIND PHARMA · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
DR REDDYS · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
FRESENIUS KABI USA · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
ZENARA · SUGAMMADEX SODIUM
- SUGAMMADEX SODIUM
SANDOZ · SUGAMMADEX SODIUM
Device recalls
FDA date:FDA posted 2 device recalls from 2 firms on Tue, Jul 28.
- Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients…
ResMed Ltd. · Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of v…
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
IsoTis OrthoBiologics, Inc. · Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were fille…
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 21 PMA decisions on Tue, Jul 21.
- PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc. · General Hospital
- One-Fil LC
Mediclus Co., Ltd. · Dental
- Raney Clips Kit
Beijing Honghugaoxiang Science and Technology Development CO · Neurology
- Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Xuzhou Kernel Medical Equipment Co., Ltd. · Unknown
- Versalock Proximal Tibial Plating System
GM Dos Reis Industria e Comercio Ltda. · Orthopedic
- Medical Thulium Fiber Laser Systems (UroFiber 150Q)
Rhein Laser Technologies Co., Ltd. · General, Plastic Surgery
- OTTAVA Robotic Surgical System
Auris Health, Inc., part of Johnson & Johnson MedTech · General, Plastic Surgery
- CardIQ Suite
GE Medical Systems SCS · Radiology
- ResolutionMD
ResolutionMD, Inc. · Radiology
Label updates
FDA date:207 drug labels took effect on Tue, Jul 21. Below: those, and labels carrying a boxed warning.
- BICILLIN L-A
PENICILLIN G BENZATHINE · Pfizer Laboratories Div Pfizer Inc · INTRAMUSCULAR
- capecitabine
CAPECITABINE · NorthStar RxLLC · ORAL
- Lyfgenia
LOVOTIBEGLOGENE AUTOTEMCEL · Genetix Biotherapeutics Inc. · INTRAVENOUS
- Lisinopril
LISINOPRIL · Aurobindo Pharma Limited · ORAL
- TOFACITINIB CITRATE
TOFACITINIB CITRATE · ScieGen Pharmaceuticals, INC. · ORAL
- TOFACITINIB CITRATE
TOFACITINIB CITRATE · Radha Pharmaceuticals, Inc. · ORAL
- CELECOXIB
CELECOXIB · REMEDYREPACK INC. · ORAL
How the FDA daily is written
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 and 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. Complete response letters appear the day after FDA publishes a batch.
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