FDA Daily

FDA daily for Wednesday, September 23, 2026

431 FDA records across 7 sections. 25 touch MedGrid's categories and are listed first.

431FDA Records

7 of 7Sections With Data

25Touch MedGrid Categories

Drug shortagesCovers FDA's Tue, Sep 22 (yesterday)

12 touch MedGrid179

Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .8 g/100 mL (NDC 0264-9598-20) — B. Braun Medical Inc.
Reverified · Current · Cardiovascular
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .4 g/100 mL (NDC 0264-9594-20) — B. Braun Medical Inc.
Reverified · Current · Cardiovascular
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride, Injection, 200 mg/10 mL (2%; 20 mg/mL) (NDC 0409-4282-02) — Hospira, Inc., a Pfizer Company
Reverified · Current · Anesthesia
Liraglutide InjectionTouches MedGrid categories
Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) — Novo Nordisk, Inc.
Reverified · Current · Endocrinology/Metabolism
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Epinephrine, Injection, 250 mg/50 mL (0.5%; 1:200,000) (NDC 0409-3177-01) — Hospira, Inc., a Pfizer Company
Revised · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Epinephrine, Injection, 300 mg/30 mL (1%; 1:100,000) (NDC 0409-3178-02) — Hospira, Inc., a Pfizer Company
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride Preservative Free In Plastic Container, Injection, 50 mg/5mL (1%, 10 mg/1 mL) Syringes (NDC 0409-9137-05) — Hospira, Inc., a Pfizer Company
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:200,000) (NDC 0409-3183-01) — Hospira, Inc., a Pfizer Company
Reverified · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride, Injection, 100 mg/5 mL (2%; 20 mg/mL) (NDC 0409-2066-05) — Hospira, Inc., a Pfizer Company
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Epinephrine, Injection, 75 mg/5 mL (1.5%; 1:200,000) (NDC 0409-1209-01) — Hospira, Inc., a Pfizer Company
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride In Plastic Container, Injection, 200 mg/20 mL (1%; 10 mg/mL) (NDC 0409-4276-01) — Hospira, Inc., a Pfizer Company
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride And Epinephrine, Injection, 200 mg/20 mL (1%; 1:100,000) (NDC 0409-3178-01) — Hospira, Inc., a Pfizer Company
Revised · Current · Anesthesia

Showing 12 of 179. Search the rest in openFDA.

Drug approvalsCovers FDA's Wed, Sep 16 (a week ago)

ZORTRESS
EVEROLIMUS — NOVARTIS
NDA021560 · Labeling
TRANEXAMIC ACID
TRANEXAMIC ACID — HERITAGE
ANDA202436 · Labeling
GABAPENTIN
GABAPENTIN — PAI HOLDINGS PHARM
ANDA211330 · Labeling
XELJANZ
TOFACITINIB CITRATE — PFIZER
NDA213082 · Labeling
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE — STRIDES PHARMA
ANDA205077 · Labeling
XELJANZ
TOFACITINIB CITRATE — PF PRISM CV
NDA203214 · Labeling
XELJANZ XR
TOFACITINIB CITRATE — PFIZER
NDA208246 · Labeling
OLANZAPINE
OLANZAPINE — MACLEODS PHARMS LTD
ANDA202862 · Labeling
METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE — OXFORD PHARMS
ANDA202892 · Labeling
MELOXICAM
MELOXICAM — AUROBINDO PHARMA
ANDA078008 · Labeling
TRUQAP
CAPIVASERTIB — ASTRAZENECA
NDA218197 · Efficacy
GLUCAGON
GLUCAGON HYDROCHLORIDE — FRESENIUS KABI USA
NDA201849 · Labeling

Showing 12 of 15. Search the rest in openFDA.

Drug recallsCovers FDA's Wed, Sep 16 (a week ago)

OurPharma LLC
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01. — Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Class II · AR · Ongoing
ImprimisRx NJ LLC
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10 — Subpotent Drug
Class III · NJ · Ongoing
American Regent, Inc.
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-30… — Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class I · NY · Ongoing
Ajanta Pharma USA Inc
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. — Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Class III · NJ · Ongoing
Baxter Healthcare Corporation
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06 — Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · IL · Ongoing
B BRAUN MEDICAL INC
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32. — Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · PA · Ongoing

Food and supplement recallsCovers FDA's Wed, Sep 16 (a week ago)

EURO FOODS GROUP USA NJ INC
Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen — The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.
Class I · NJ · Ongoing
L-Nutra Inc
Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530 — Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.
Class II · CA · Ongoing
EXOTIQUE FOODS CANADA
Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly M… — Undeclared Wheat.
Class I · Ongoing
International Sprout Holdings, Inc
Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506 — Potential E. coli and Salmonella contamination
Class I · TN · Ongoing
Ferrero USA
Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz — Undeclared milk and pecans
Class II · OH · Ongoing

Device recallsCovers FDA's Wed, Sep 16 (a week ago)

8 touch MedGrid20

Nipro Renal Soultions USA, CorporationTouches MedGrid categories
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 — Hemodialysis concentrates contain high endotoxin levels
Class II · PA · Ongoing
Lutronic CorporationTouches MedGrid categories
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system… — Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Class II · Ongoing
Atrium Medical CorporationTouches MedGrid categories
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036); — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Class II · NH · Ongoing
Atrium Medical CorporationTouches MedGrid categories
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036); — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Class II · NH · Ongoing
Nipro Renal Soultions USA, CorporationTouches MedGrid categories
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X) — Hemodialysis concentrates contain high endotoxin levels
Class II · PA · Ongoing
Nipro Renal Soultions USA, CorporationTouches MedGrid categories
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) — Hemodialysis concentrates contain high endotoxin levels
Class II · PA · Ongoing
Nipro Renal Soultions USA, CorporationTouches MedGrid categories
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 — Hemodialysis concentrates contain high endotoxin levels
Class II · PA · Ongoing
Atrium Medical CorporationTouches MedGrid categories
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136); — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Class II · NH · Ongoing
C.R. Bard Inc
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley… — Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Class II · GA · Ongoing
C.R. Bard Inc
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 108017410249… — Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Class II · GA · Ongoing
HeartSine Technologies Ltd
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English… — Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Class II · Ongoing
C.R. Bard Inc
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801… — Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Class II · GA · Ongoing

Showing 12 of 20. Search the rest in openFDA.

Device clearancesCovers FDA's Wed, Sep 9 (two weeks ago)

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Colo…
Maxter Healthcare, Inc.
K261793 · Substantially Equivalent · General Hospital
ChestView US (1.1)
Gleamer
K252486 · Substantially Equivalent · Radiology
ReVISION 2
Argus Cognitive, Inc.
K251417 · Substantially Equivalent · Radiology
ColActive Plus
Covalon Technologies, Ltd.
K260652 · Substantially Equivalent · Unknown
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet…
Top Glove Sdn. Bhd.
K262542 · Substantially Equivalent · General Hospital
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
Endoclot Plus Co., Ltd.
K260997 · Substantially Equivalent · Gastroenterology, Urology
QF10
E.A.M Benelux B.V
K261470 · Substantially Equivalent · Gastroenterology, Urology
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
Guangzhou Red Pine Medical Instrument Co., Ltd.
K262488 · Substantially Equivalent · Gastroenterology, Urology

Label changesCovers FDA's Wed, Sep 9 (two weeks ago)

5 touch MedGrid198

Etonogestrel and Ethinyl Estradiol VaginalTouches MedGrid categories
AvKARE
Label version 7
SunscreenTouches MedGrid categories
1226 W AESTHETICS
Label version 1
Stay Ageless Tinted Mineral SunscreenTouches MedGrid categories
W Aesthetics
Label version 1
5% Lidocaine 10gTouches MedGrid categories
Chongqing Mandongzi Technology Co., Ltd
Label version 1
4% Lidocaine Pain Relief PatchTouches MedGrid categories
Guangxi Keyun E-commerce Co., Ltd.
Label version 1
Drug label
Label version 4
Metformin
REMEDYREPACK INC.
Label version 5
Bendamustine Hydrochloride
Apotex Corp
Label version 9
Nicotine
Rite Aid Corporation
Label version 3
SENOKOT
A-S Medication Solutions
Label version 1
Ibuprofen
Lidl US LLC
Label version 5
SPIRONOLACTONE
Bryant Ranch Prepack
Label version 11

Showing 12 of 198. 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.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

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, September 23, 2026

Sections in This Issue