FDA daily for Wednesday, July 29, 2026
327 FDA records across 6 sections. 12 touch MedGrid's categories and are listed first.
Drug approvalsCovers FDA's Wed, Jul 22 (a week ago)14
- ADAPALENE AND BENZOYL PEROXIDE
ADAPALENE, BENZOYL PEROXIDE — AUROBINDO PHARMA LTD
- METHYLPHENIDATE
METHYLPHENIDATE — MYLAN TECH VIATRIS
- REVLIMID
LENALIDOMIDE — BRISTOL MYERS SQUIBB
- METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE — LUPIN LTD
- CHILDREN'S MOTRIN
IBUPROFEN — KENVUE BRANDS
- EDARAVONE
EDARAVONE — ZYDUS PHARMS
- TOPIRAMATE
TOPIRAMATE — BIOCON PHARMA
- NEURACEQ
FLORBETABEN F-18 — LANTHEUS
- GABAPENTIN
GABAPENTIN — RISING
- VERAPAMIL HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE — KNACK
- CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE — WATSON LABS
- METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE — IMPAX LABS
Showing 12 of 14. Search the rest in openFDA.
Drug recallsCovers FDA's Wed, Jul 22 (a week ago)14
- Chiesi USA, Inc.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611… — Lack of Assurance of Sterility
- Bell Pharmaceuticals, Inc
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, M… — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Produ… — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320. — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- CareFusion 213, LLC
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, sub… — Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- Bell Pharmaceuticals, Inc
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Padagis US LLC
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 — Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Bell Pharmaceuticals, Inc
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsoc… — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VIL… — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- Bell Pharmaceuticals, Inc
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO… — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Showing 12 of 14. Search the rest in openFDA.
Food and supplement recallsCovers FDA's Wed, Jul 22 (a week ago)2 touch MedGrid26
- Nutricia North AmericaTouches MedGrid categories
functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 00453 3, package UPC 8 57858 00450 2 — Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
- Nutricia North AmericaTouches MedGrid categories
functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 OZ (341g) case UPC 8 57858 00445 8, package UPC 8 57858 0044… — Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Tamarindo, 1 Bar (81.7 g), with UPC 827912008593 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Arroz con Leche, 4 oz (85 g), with UPC 710594511843 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- Fayus Inc.
OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA INGREDIENTS: Pounded Groundnuts (Intwilo) UPC: 650… — Undeclared peanuts
- GELLERT GLOBAL GROUP
Ruby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry conditions . — Foreign material (Glass) was found in the product.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Fresa Leche, 4 oz (85 g), with UPC 710594511850 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Limon, 4 oz (85 g), with UPC 710594511836 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
- D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487 — May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Showing 12 of 26. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Jul 22 (a week ago)7 touch MedGrid49
- Argon Medical Devices, IncTouches MedGrid categories
General Biospy Tray, REF: GUTS1000 — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Tosoh Bioscience IncTouches MedGrid categories
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204 — The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone resu…
- Argon Medical Devices, IncTouches MedGrid categories
Arterial Line Kit 20ga x 6, REF: 400115A — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Argon Medical Devices, IncTouches MedGrid categories
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Argon Medical Devices, IncTouches MedGrid categories
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Argon Medical Devices, IncTouches MedGrid categories
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Argon Medical Devices, IncTouches MedGrid categories
Bone Marrow Tray, REF: CB0033TL; CB0355TLA — Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Orthofix U.S. LLC
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device — Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Boston Scientific Corporation
Rapid Refill Continuous Injection System, UPN M00566001 — Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection…
- Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories — A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or…
- Papablic Inc
Papablic Replacement Brush Heads. Model Number: PAPA317AA. — Potential for brush heads to break.
- Papablic Inc
Papablic Replacement Brush Heads. Model Number: Papablic18B — Potential for brush heads to break.
Showing 12 of 49. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Jul 15 (two weeks ago)11
- Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
Atlas Spine, Inc.
- XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE45…
Dongguan Miqiang Technology Co., Ltd.
- Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
Kyocera Medical Technologies, Inc.
- Profoject Pen Needles (Model A; Model B)
CMT Health PTE., Ltd.
- WRAP System
Huneo, LLC
- NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K.
- Aventus Thrombectomy System
Inquis Medical
- SkeletonPlanner
UPlanner B.V. - Presurgeo
- ThinkSono Guidance
ThinkSono GmbH
- Better Diagnostics Dental Assist (BDDA) Version 1.0
Better Diagnostics AI Corp.
- EnSite X EP System
Abbott Medical
Label changesCovers FDA's Wed, Jul 15 (two weeks ago)3 touch MedGrid213
- BaseLife Clear UV Defense SunscreenTouches MedGrid categories
Wintech America, Inc.
- LidocaineTouches MedGrid categories
A-S Medication Solutions
- LidocaineTouches MedGrid categories
ASCLEMED USA INC.
- Drug label
- Colgate Max Fresh Advanced Whitening
Colgate-Palmolive Company
- Drug label
- Curist Hives Relief
Little Pharma, Inc.
- Drug label
- Doxycycline
Bryant Ranch Prepack
- Cimetidine
Mylan Pharmaceuticals Inc.
- Levonorgestrel
GLENMARK THERAPEUTICS INC., USA
- Fluoxetine
Aurobindo Pharma Limited
Showing 12 of 213. 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.