FDA Daily

FDA daily for Wednesday, October 7, 2026

286 FDA records across 7 sections. 18 touch MedGrid's categories and are listed first.

286FDA Records

7 of 7Sections With Data

18Touch MedGrid Categories

Drug shortagesCovers FDA's Tue, Oct 6 (yesterday)

12 touch MedGrid174

Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-57) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, 15 mg/1 mL (NDC 63323-493-91) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-27) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-27) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Lidocaine Hydrochloride, Injection, 20 mg/1 mL (NDC 63323-202-02) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-17) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, 5 mg/1 mL (NDC 63323-491-57) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, 20 mg/1 mL (NDC 63323-495-07) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-17) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, 10 mg/1 mL (NDC 63323-485-57) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia
Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, 10 mg/1 mL (NDC 63323-492-57) — Fresenius Kabi USA, LLC
Reverified · Current · Anesthesia
Epinephrine Bitartrate, Lidocaine Hydrochloride InjectionTouches MedGrid categories
Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-27) — Fresenius Kabi USA, LLC
Revised · Current · Anesthesia

Showing 12 of 174. Search the rest in openFDA.

Drug approvalsCovers FDA's Wed, Sep 30 (a week ago)

CAMZYOS
MAVACAMTEN — BRISTOL
NDA214998 · Efficacy
ATOMOXETINE HYDROCHLORIDE
ATOMOXETINE HYDROCHLORIDE — PHARMAZONE
ANDA218875 · Labeling
CELECOXIB
CELECOXIB — PHARMAZONE
ANDA210628 · Labeling
ACETAZOLAMIDE
ACETAZOLAMIDE — EPIC PHARMA LLC
ANDA218023 · Labeling
DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE — ALEMBIC
ANDA215076 · Labeling
INDOMETHACIN
INDOMETHACIN — MYLAN
ANDA202139 · Labeling
LEVOCARNITINE
LEVOCARNITINE — GLAND
ANDA220181 · Original approval
METHOTREXATE SODIUM
METHOTREXATE SODIUM — FRESENIUS KABI USA
ANDA040263 · Manufacturing (CMC)
MATULANE
PROCARBAZINE HYDROCHLORIDE — LEADIANT BIOSCI INC
NDA016785 · Labeling
PHYTONADIONE
PHYTONADIONE — LUPIN
ANDA219175 · Original approval
XENICAL
ORLISTAT — CHEPLAPHARM
NDA020766 · Labeling
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE — TARO
ANDA220722 · Original approval

Showing 12 of 14. Search the rest in openFDA.

Drug recallsCovers FDA's Wed, Sep 30 (a week ago)

1 touch MedGrid14

SHANTOU Qiwei industrial Co., LtdTouches MedGrid categories
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guan… — cGMP Deviations
Class II · Ongoing
Sterling Pharmaceutical Services LLC
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci… — Lack of Assurance of Sterility
Class II · IL · Ongoing
Sterling Pharmaceutical Services LLC
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 3… — Lack of Assurance of Sterility
Class II · IL · Ongoing
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Produc… — Lack of Assurance of Sterility
Class II · NY · Ongoing
Sterling Pharmaceutical Services LLC
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15 — Lack of Assurance of Sterility
Class II · IL · Ongoing
Sterling Pharmaceutical Services LLC
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 4249… — Lack of Assurance of Sterility
Class II · IL · Ongoing
Sterling Pharmaceutical Services LLC
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-0… — Lack of Assurance of Sterility
Class II · IL · Ongoing
Sterling Pharmaceutical Services LLC
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15. — Lack of Assurance of Sterility
Class II · IL · Ongoing
Amneal Pharmaceuticals of New York, LLC
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India… — Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · NY · Ongoing
Macleods Pharmaceuticals Limited
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDI… — Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III · Ongoing
Sterling Pharmaceutical Services LLC
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38 — Lack of Assurance of Sterility
Class II · IL · Ongoing
Sterling Pharmaceutical Services LLC
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-883… — Lack of Assurance of Sterility
Class II · IL · Ongoing

Showing 12 of 14. Search the rest in openFDA.

Food and supplement recallsCovers FDA's Wed, Sep 30 (a week ago)

WFM Purchasing, LP
Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme Shelf life: 30 days, all dates through and including 10/7/2026 Packaging: Plastic wrapped by slice Net Wt.: Various, cut from whole wheel a… — Undeclared Egg Allergen
Class I · TX · Ongoing
GIAS FOOD INC.
Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine, MADE IN ITALY, NET WT 22 OZ, BEST if Used B… — Contamination with Listeria monocytogenes
Class I · NY · Ongoing
Kwok Shing, Inc.
American Ginsengs. PRODUCT OF WISCONSIN. NET WT: 4 oz. NET WT. 8 oz. — Potential contamination with pesticides.
Class III · CA · Ongoing
United Sugar Producers and Refiners
Light Brown Sugar, Packaged in he follow configurations: 1. United, Net Wt. 50 lbs., (22.68kg). Item Number 810051. Distributed By: United Sugar Producers & Refiners, Minneapolis, MN 55439. 2. Good &… — Potential Wheat Kernel contamination.
Class II · MN · Ongoing
Unilever North America Supply Chain Company, LLC
Almond Joy Ice Cream Bar, 2.0 fl. oz. ice cream bars, paper cartons containing individually wrapped ice cream bars . 6 bars per carton. Keep frozen — Inaccurate Nutrition Facts information listed on product
Not Yet Classified · NJ · Ongoing
United Sugar Producers and Refiners
Powdered Sugar, Packaged in the following configurations: 1. United 6X, Net Wt. 50 lbs. (22.68kg), Item Number 810087. UPC 7 85921-07090 4. Distributed by: United Sugar Producers & Refiners, Minneapo… — Potential Wheat Kernel contamination.
Class II · MN · Ongoing
WWF Operating Company
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. 16 oz paper tub with an attached paper lid. Sold as a single unit multi serving tub. UPC 744473 476138. Distribute… — Product may contain foreign material: small stones and other hard objects.
Class II · CO · Ongoing
Evergreen Fresh Sprouts LLC
Evergreen Fresh Sprouts LLC, Broccoli Sprouts, packaged in clear plastic zip lock bag, net wt. 4oz, UPC 8 38796 00105 1. Firm distributed cases (6/4oz. bags per case) to distributor. — Salmonella
Class I · ID · Ongoing
Elegant Foods, LLC
Pecorino Toscano D.O.P. STAGIONATO cheese wheels. Product of Italy. Each cheese wheel is approximately 3-4 lbs. Wheels contain a wax rind. Keep Refrigerated. Produced by Soc. Cooperativa Val D'Orcia… — Potential Listeria contamination from dripping condensation in cooler.
Class II · WI · Ongoing

Device recallsCovers FDA's Wed, Sep 30 (a week ago)

5 touch MedGrid56

Medline Industries, LPTouches MedGrid categories
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CR… — The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as ne…
Class II · IL · Ongoing
Medline Industries, LPTouches MedGrid categories
Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PA… — The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as ne…
Class II · IL · Ongoing
Medline Industries, LPTouches MedGrid categories
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLU… — The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as ne…
Class II · IL · Ongoing
Medline Industries, LPTouches MedGrid categories
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ506… — The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as ne…
Class II · IL · Ongoing
Medline Industries, LPTouches MedGrid categories
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A — The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as ne…
Class II · IL · Ongoing
Olympus Corporation of the Americas
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. — Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Class II · PA · Ongoing
Medline Industries, LP
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F. — Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion an…
Class II · IL · Ongoing
Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patient… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Class II · OH · Ongoing
Philips North America Llc
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; — A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Class II · MA · Ongoing
Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Package… — Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system perfo…
Class II · MA · Ongoing
CooperSurgical, Inc.
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715. — Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and…
Class I · CT · Ongoing
Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patient… — A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Class II · OH · Ongoing

Showing 12 of 56. Search the rest in openFDA.

Device clearancesCovers FDA's Wed, Sep 23 (two weeks ago)

Everslide
Special Situations, LLC
K260117 · Substantially Equivalent · Obstetrics/Gynecology
BTL-299-F
BTL Industries, Inc.
K262353 · Substantially Equivalent · Gastroenterology, Urology
Syneris PACS v.1.0.1.0
Syneris
K261874 · Substantially Equivalent · Radiology
G7® Acetabular System
Zimmer Biomet
K261453 · Substantially Equivalent · Orthopedic
Cemented Plus Abutment
Unidental Co., Ltd.
K262207 · Substantially Equivalent · Dental
DynaNail Helix® Fixation System
MedShape, Inc.
K260995 · Substantially Equivalent · Orthopedic
iFuse Granite Onyx Implant System
SI-BONE, Inc.
K262067 · Substantially Equivalent · Orthopedic
Hair Growth Comb (X-GC01)
Guangdong Ashmore Health Technology Co., Ltd.
K262254 · Substantially Equivalent · Physical Medicine
Liquick X-treme, Liquick X-treme Plus
Teleflex Medical
K261418 · Substantially Equivalent · Gastroenterology, Urology
Single-use Flexible Bronchoscope
Hunan Vathin Medical Instrument Co., Ltd.
K261637 · Substantially Equivalent · Ear, Nose, Throat
Electric wheelchair (GP100)
Suzhou Green Pine Medical Co., Ltd.
K262582 · Substantially Equivalent · Physical Medicine
Anti-HCV Next
Abbott Laboratories
K262156 · Substantially Equivalent · Microbiology

Showing 12 of 17. Search the rest in openFDA.

Label changesCovers FDA's Wed, Sep 23 (two weeks ago)

Meridian Anticavity Cinnamon
Bob Barker Company Inc.
Label version 1
Triamcinolone Acetonide
A-S Medication Solutions
Label version 16

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, October 7, 2026

Sections in This Issue