Skip to content
Physician-backed infrastructure for aesthetic & wellness practicesSupport 9 AM–5 PM EST ·(888) 996-6173 ·info@medgrid.com
MedGrid
Book Free Consult
FDA Daily

FDA daily for Wednesday, July 22, 2026

246 FDA records across 6 sections. 10 touch MedGrid's categories and are listed first.

246FDA Records
6 of 7Sections With Data
10Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Tue, Jul 21 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Wed, Jul 15 (a week ago)
1 touch MedGrid14
  • ENDOMETRINTouches MedGrid categories

    PROGESTERONE — FERRING

    NDA022057 · Labeling

  • ETODOLAC

    ETODOLAC — AUROBINDO PHARMA LTD

    ANDA214872 · Original approval

  • ROCURONIUM BROMIDE

    ROCURONIUM BROMIDE — FRESENIUS KABI USA

    NDA217472 · Labeling

  • LIPFENDRA

    ENLICITIDE DECANOATE — MSD

    NDA220848 · Original approval

  • TEGRETOL

    CARBAMAZEPINE — NOVARTIS

    NDA016608 · Labeling

  • TEGRETOL

    CARBAMAZEPINE — NOVARTIS

    NDA018927 · Labeling

  • STELARA

    USTEKINUMAB — JANSSEN BIOTECH

    BLA761044 · Labeling

  • DUPIXENT

    DUPILUMAB — REGENERON PHARMACEUTICALS

    BLA761055 · Labeling

  • STELARA

    USTEKINUMAB — CENTOCOR ORTHO BIOTECH INC

    BLA125261 · Labeling

  • METFORMIN HYDROCHLORIDE

    METFORMIN HYDROCHLORIDE — ZYDUS LIFESCIENCES

    ANDA077060 · Labeling

  • METFORMIN HYDROCHLORIDE

    METFORMIN HYDROCHLORIDE — ZYDUS LIFESCIENCES

    ANDA077078 · Labeling

  • REPATHA

    EVOLOCUMAB — AMGEN INC

    BLA125522 · Labeling

Showing 12 of 14. Search the rest in openFDA.

Drug recallsCovers FDA's Wed, Jul 15 (a week ago)
1 touch MedGrid14
  • QuVa Pharma, Inc.Touches MedGrid categories

    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46. — Failed Impurities/Degradation Specifications

    Class II · TX · Ongoing

  • ONESOURCE SPECIALTY PHARMA LIMITED

    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc… — Failed Impurities/Degradation Specifications

    Class II · N/A · Ongoing

  • Gasco Industrial Corp.

    Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA — Subpotent drug

    Class II · PR · Ongoing

  • Gasco Industrial Corp.

    Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6. — Subpotent drug

    Class II · PR · Ongoing

  • Gasco Industrial Corp.

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567. — Subpotent drug

    Class II · PR · Ongoing

  • Shimoga Chemicals

    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Ad… — cGMP deviations

    Class II · N/A · Ongoing

  • Reliance Life Sciences Private Limited

    Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01 — Lack of Sterility Assurance

    Class II · N/A · Ongoing

  • Gasco Industrial Corp.

    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3 — Subpotent drug

    Class II · PR · Ongoing

  • Gasco Industrial Corp.

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924 — Subpotent drug

    Class II · PR · Ongoing

  • Reliance Life Sciences Private Limited

    Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 — Lack of Sterility Assurance

    Class II · N/A · Ongoing

  • Reliance Life Sciences Private Limited

    Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01 — Lack of Sterility Assurance

    Class II · N/A · Ongoing

  • Reliance Life Sciences Private Limited

    Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-… — Lack of Sterility Assurance

    Class II · N/A · Ongoing

Showing 12 of 14. Search the rest in openFDA.

Food and supplement recallsCovers FDA's Wed, Jul 15 (a week ago)
13
  • Adams Extract & Spice LLC

    Smoked Sausage Spice 32.86# — Undeclared Sesame allergen

    Class I · TX · Terminated

  • Bear Stewart Co

    Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case — undeclared soy

    Class II · IL · Terminated

  • Adams Extract & Spice LLC

    EC Hot Links Seasoning 45.05# — Undeclared Sesame allergen

    Class I · TX · Terminated

  • Wise Foods Inc

    Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case, — The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.

    Class II · PA · Ongoing

  • Trafa Pharmaceutical Inc.

    Trafa Pharmaceuticals Inc. brand ORGANIC MORINGA LEAF POWDER; NET WEIGHT: 15 KGS; packaged in brown paper bags with a white label — Potential contamination with Salmonella

    Class I · MA · Ongoing

  • Specialty Bakers, LLC

    Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1 plastic tray which holds 6 desserts shells. Plastic is… — Undeclared Allergen (Soy)

    Class II · PA · Terminated

  • Adams Extract & Spice LLC

    Coopers Bbq 60 Gal Bean Mix box — Undeclared Sesame allergen

    Class I · TX · Terminated

  • Fresh & Ready Foods LLC

    Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufactured By LPK1 Renton, WA. Product was not sold at retail stores and sold only to emplo… — Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

    Class I · WA · Terminated

  • Wondermade LLC

    Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box — Foreign material: small metal pieces

    Class II · FL · Ongoing

  • Adams Extract & Spice LLC

    JB Chicken Sknls 35.73# — Undeclared Sesame allergen

    Class I · TX · Terminated

  • Lehi Valley Trading Company, Inc

    High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0.… — Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.

    Class I · AZ · Terminated

  • Fresh & Ready Foods LLC

    Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufactured by LPK1 Renton, WA. Product was not sold at retail stores an… — Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

    Class I · WA · Terminated

Showing 12 of 13. Search the rest in openFDA.

Device recallsCovers FDA's Wed, Jul 15 (a week ago)
20
  • ConvaTec, Inc

    Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R — Surgical dressing manufactured out of specification (greater thickness).

    Class II · NC · Ongoing

  • WALLAC OY

    GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. — Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

    Class II · N/A · Ongoing

  • Klowen Braces

    KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, — A product error defect may cause incorrect bracket placement.

    Class II · TX · Ongoing

  • Medtronic MiniMed, Inc.

    MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 — A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 foll…

    Class II · CA · Ongoing

  • Olympus Corporation of the Americas

    Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the i… — Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

    Class II · PA · Ongoing

  • CMR SURGICAL LIMITED

    Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical Sys… — Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

    Class II · N/A · Ongoing

  • Medline Industries, LP

    Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A — Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9…

    Class II · IL · Ongoing

  • Siemens Healthcare Diagnostics, Inc.

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. — The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

    Class II · NY · Ongoing

  • Elekta, Inc.

    Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecolog… — Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

    Class II · GA · Ongoing

  • Fresenius Medical Care Holdings, Inc.

    5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood… — Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.

    Class II · MA · Ongoing

  • Elekta, Inc.

    Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for… — Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

    Class II · GA · Ongoing

  • Elekta, Inc.

    Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional… — Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

    Class II · GA · Ongoing

Showing 12 of 20. Search the rest in openFDA.

Device clearancesCovers FDA's Wed, Jul 8 (two weeks ago)
10
  • Virtual Cone (1.0)

    Varian Medical Systems, Inc.

    K260750 · Substantially Equivalent · Radiology

  • ThermAffyx(TM) Patient Safety System

    Stihler Electronic GmbH

    K260278 · Substantially Equivalent · Cardiovascular

  • Alians Elbow S

    Newclip Technics

    K261191 · Substantially Equivalent · Orthopedic

  • cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems

    Roche Molecular Systems, Inc.

    K260917 · Substantially Equivalent · Microbiology

  • Denture Base Resin V2

    Formlabs Ohio, Inc.

    K262300 · Substantially Equivalent · Dental

  • VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

    bioMerieux, Inc.

    K260160 · Substantially Equivalent · Microbiology

  • Electric Wheelchair

    Ningbo Resshidi Medical Devices Co., Ltd.

    K261396 · Substantially Equivalent · Physical Medicine

  • CXRDetectAI

    Neurocareai, Inc. (Dba Savelife.Ai)

    K253751 · Substantially Equivalent · Radiology

  • C.A. Medical Interbody Fusion System

    C.A. Medical, LLC

    K254130 · Substantially Equivalent · Orthopedic

  • BlueDop Vascular Expert

    BlueDop Medical, Ltd.

    K260700 · Substantially Equivalent · Cardiovascular

Label changesCovers FDA's Wed, Jul 8 (two weeks ago)
8 touch MedGrid175
  • Sunny C Sunscreen SPF 50Touches MedGrid categories

    MIXIK, INC.

    Label version 3

  • Bombee Honey Daily Glow Shield SunscreenTouches MedGrid categories

    ABT ASIA Inc.

    Label version 1

  • Nupharmisto 4% Lidocaine Numbing creamTouches MedGrid categories

    EveryMarket Inc

    Label version 1

  • ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREENTouches MedGrid categories

    COSMAX USA, CORPORATION

    Label version 1

  • Welmate Numbing ReliefTouches MedGrid categories

    YYBA Corp

    Label version 1

  • Care ScienceTouches MedGrid categories

    ASO LLC

    Label version 1

  • Stay Ageless Tinted Mineral SunscreenTouches MedGrid categories

    DERMIO DERMATOLOGY LLC

    Label version 1

  • Stay Ageless Tinted Mineral SunscreenTouches MedGrid categories

    Suzanne's Skin2soul LLC

    Label version 1

  • Paroxetine

    REMEDYREPACK INC.

    Label version 11

  • Drug label

    Label version 5

  • Vancomycin Hydrochloride

    Meitheal Pharmaceuticals Inc.

    Label version 6

  • topiramate

    REMEDYREPACK INC.

    Label version 17

Showing 12 of 175. 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.