FDA Daily

FDA daily for Wednesday, August 26, 2026

279 FDA records across 7 sections. 36 touch MedGrid's categories and are listed first.

279FDA Records

7 of 7Sections With Data

36Touch MedGrid Categories

Drug shortagesCovers FDA's Tue, Aug 25 (yesterday)

1 touch MedGrid2

Liraglutide InjectionTouches MedGrid categories
Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) — Novo Nordisk, Inc.
New · To Be Discontinued · Endocrinology/Metabolism
Mesalamine Capsule, Extended Release
Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78) — Mylan Pharmaceuticals Inc., a Viatris Company
New · To Be Discontinued · Gastroenterology

Drug approvalsCovers FDA's Wed, Aug 19 (a week ago)

1 touch MedGrid12

ESTRADIOLTouches MedGrid categories
ESTRADIOL — ENCUBE
ANDA218507 · Labeling
PASATRU
GARETOSMAB-GRTS — REGENERON PHARMACEUTICALS, INC
BLA761508 · Original approval
NINTEDANIB ESYLATE
NINTEDANIB ESYLATE — BIOCON PHARMA
ANDA220118 · Original approval
FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE — QILU PHARM HAINAN
ANDA213106 · Labeling
METAXALONE
METAXALONE — LANNETT CO INC
ANDA204770 · Labeling
L-GLUTAMINE
L-GLUTAMINE — NOVITIUM PHARMA
ANDA215647 · Labeling
LEQVIO
INCLISIRAN SODIUM — NOVARTIS
NDA214012 · Labeling
RAMIPRIL
RAMIPRIL — AUROBINDO PHARMA LTD
ANDA091604 · Labeling
MYCOPHENOLATE SODIUM
MYCOPHENOLATE SODIUM — BIOCON PHARMA
ANDA217031 · Labeling
COLISTIMETHATE SODIUM
COLISTIMETHATE SODIUM — FRESENIUS KABI USA
ANDA065364 · Labeling
BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE — INVAGEN PHARMS
ANDA206556 · Labeling
RIVAROXABAN
RIVAROXABAN — EPIC PHARMA LLC
ANDA216255 · Original approval

Drug recallsCovers FDA's Wed, Aug 19 (a week ago)

12 touch MedGrid23

Shoolin Pharma Chem LLPTouches MedGrid categories
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Ma… — CGMP Deviations:Noted during FDA inspection
Class II · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-… — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Victory Medical Center PharmacyTouches MedGrid categories
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC. — Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · TX · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-… — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04. — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Apollo Care, LLCTouches MedGrid categories
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02 — Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · MO · Ongoing
Shoolin Pharma Chem LLPTouches MedGrid categories
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania,… — CGMP Deviations:Noted during FDA inspection
Class II · Ongoing

Showing 12 of 23. Search the rest in openFDA.

Food and supplement recallsCovers FDA's Wed, Aug 19 (a week ago)

MIDWEST POULTRY SERVC C/O H & LELECTRIC
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati,… — Possible Salmonella Enteritidis
Class I · IN · Terminated
Taylor Farms de Mexico S. de R.L. de C.V.
MARKON LETTUCE SALAD MIX 4/5# MARKON LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products. — Potential Cyclospora contamination.
Class I · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
Jack in the Box 1/8" SHRED LETTUCE 4/5# Iceberg only products. — Potential Cyclospora contamination.
Class I · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
Cross Valley Farms BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products. — Potential Cyclospora contamination.
Class I · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
SUBWAY SHRED LETTUCE 1/4" 4/5# Iceberg only products. — Potential Cyclospora contamination.
Class I · Ongoing
Bazzini LLC
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case. — Undeclared peanuts
Class I · PA · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
TAYLOR FARMS BLEND LETT/ROM BLEND WITH BAG 4/5# Iceberg, Romaine, Carrots, Red Cabbage products. — Potential Cyclospora contamination.
Class I · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
MARKON BLEND LETT/ROM 50/50 NOCLR 4/5# MARKON BLEND LETT/ROM 80/20 4/5# Iceberg, Romaine products. — Potential Cyclospora contamination.
Class I · Ongoing
FlavorsandColor.Com
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730 — Undeclared Red #40.
Class III · CA · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products. — Potential Cyclospora contamination.
Class I · Ongoing
Taylor Farms de Mexico S. de R.L. de C.V.
TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# NATIONAL TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# ND TAYLOR FARMS BLEND LETT/ROM 50/50 NOCLR 4/5# TAYLOR FARMS BLEND LETT/ROM 70/30 NOCOLR 4/5# TA… — Potential Cyclospora contamination.
Class I · Ongoing
SHEANDRO LLC
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton. — Label declares cream and cheese, but Milk is not declared
Class II · FL · Terminated

Showing 12 of 28. Search the rest in openFDA.

Device recallsCovers FDA's Wed, Aug 19 (a week ago)

10 touch MedGrid38

Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC;… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Spectra Medical Devices, LlcTouches MedGrid categories
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwellin… — Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This…
Class I · MA · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,AS… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CH… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) N… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Cardinal Health 200, LLCTouches MedGrid categories
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number… — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Class II · IL · Ongoing
Covidien, LPTouches MedGrid categories
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31 — Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or…
Class II · CT · Ongoing
W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. — 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Class II · AZ · Ongoing
Covidien, LP
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025… — Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or…
Class II · CT · Ongoing

Showing 12 of 38. Search the rest in openFDA.

Device clearancesCovers FDA's Wed, Aug 12 (two weeks ago)

Large Compression Screws
TriMed, Inc.
K262344 · Substantially Equivalent · Orthopedic
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pu…
Hangzhou Ruidi Biotechnology , Ltd.
K253846 · Substantially Equivalent · General, Plastic Surgery
BA-004CC
Fujifilm Corporation
K261170 · Substantially Equivalent · Radiology
NeuroQuant PET
Cortechs Labs, Inc.
K261916 · Substantially Equivalent · Radiology
EluPro Antibiotic-Eluting BioEnvelope
Boston Scientific
K262406 · Substantially Equivalent · General, Plastic Surgery
APRO 35 Swift Catheter and Alembic Aspiration Tubing
Alembic, LLC
K262391 · Substantially Equivalent · Cardiovascular
GF-310R Multigas Unit (GF-310R)
Nihon Kohden Corporation
K251641 · Substantially Equivalent · Anesthesiology
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
Hologic, Inc.
K262792 · Substantially Equivalent · Gastroenterology, Urology
Masimo Root Monitoring System
Masimo Corporation
K253417 · Substantially Equivalent · Cardiovascular
APRO 35 Swift Catheter
Alembic, LLC
K262392 · Substantially Equivalent · Cardiovascular
CadAI-B Dx
BeamWorks, Inc.
K260086 · Substantially Equivalent · Radiology
ManaCold Compression System
Manamed, LLC
K260944 · Substantially Equivalent · Physical Medicine

Showing 12 of 13. Search the rest in openFDA.

Label changesCovers FDA's Wed, Aug 12 (two weeks ago)

12 touch MedGrid163

Numbing CreamTouches MedGrid categories
100 KARMA INC
Label version 2
Treatonic hemorrhoid treatmentTouches MedGrid categories
100 KARMA INC
Label version 2
Lidocaine numbing creamTouches MedGrid categories
100 KARMA INC
Label version 2
Treatonic 5% Lidocaine CreamTouches MedGrid categories
100 KARMA INC
Label version 2
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)Touches MedGrid categories
EveryMarket Inc
Label version 2
Gembooxt Topical Numbing CreamTouches MedGrid categories
Guangdong Quadrant Ecological Technology Co., Ltd.
Label version 4
Treatonic 5% Lidocaine CreamTouches MedGrid categories
100 KARMA INC
Label version 2
IsibloomTouches MedGrid categories
Bryant Ranch Prepack
Label version 105
CVS Pain Relief Roll-On Lidocaine with LavenderTouches MedGrid categories
CVS Pharmacy
Label version 2
Nupharmisto NumbMD 5% Lidocaine creamTouches MedGrid categories
EveryMarket Inc
Label version 2
Nupharmisto NumbMD Lidocaine CreamTouches MedGrid categories
EveryMarket Inc
Label version 2
Nupharmisto NumbMD Lidocaine CreamTouches MedGrid categories
EveryMarket Inc
Label version 2

Showing 12 of 163. 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.

FDA daily for Wednesday, August 26, 2026

Sections in This Issue