FDA daily for Wednesday, August 5, 2026
329 FDA records across 7 sections. 13 touch MedGrid's categories and are listed first.
Drug shortagesCovers FDA's Tue, Aug 4 (yesterday)1
- Sterile Water Injection
Sterile Water, Injection, 1 mL/1 mL (NDC 0487-6105-01) — Nephron Pharmaceuticals Corporation
Drug approvalsCovers FDA's Wed, Jul 29 (a week ago)79
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — AUROBINDO PHARMA LTD
- GLYCOPHOS
SODIUM GLYCEROPHOSPHATE — FRESENIUS KABI USA
- CAVHANZA
NILOTINIB — CYCLE
- DOFETILIDE
DOFETILIDE — ANDAS 5 HOLDING
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — ALKEM LABS LTD
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — AMNEAL
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — AUROBINDO PHARMA LTD
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — ALKEM LABS LTD
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — AMNEAL
- MYCOPHENOLATE SODIUM
MYCOPHENOLATE SODIUM — CONCORD BIOTECH LTD
- MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETIL — WUXI
- LACOSAMIDE
LACOSAMIDE — MSN LABS PVT LTD
Showing 12 of 79. Search the rest in openFDA.
Drug recallsCovers FDA's Wed, Jul 29 (a week ago)4 touch MedGrid34
- Fresenius Kabi USA, LLCTouches MedGrid categories
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial:… — Presence of Particulate Matter: Hair was found in products
- Fresenius Kabi USA, LLCTouches MedGrid categories
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-… — Presence of Particulate Matter: Hair was found in products
- Asclemed USA Inc.Touches MedGrid categories
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. — Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
- Fresenius Kabi USA, LLCTouches MedGrid categories
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial:… — Presence of Particulate Matter: Hair was found in products
- Rohto-Mentholatum (Vietnam) Co., Ltd.
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietn… — Lack of Assurance of Sterility
- Major Pharmaceuticals
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distr… — Subpotent Drug
- Rohto-Mentholatum (Vietnam) Co., Ltd.
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in… — Lack of Assurance of Sterility
- Major Pharmaceuticals
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Dis… — Subpotent Drug
- Supernus Pharmaceuticals, Inc.
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc.,… — Failed Dissolution Specifications
- Major Pharmaceuticals
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC… — Subpotent Drug
- Fresenius Kabi USA, LLC
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23;… — Presence of Particulate Matter: Hair was found in products
- Major Pharmaceuticals
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC… — Subpotent Drug
Showing 12 of 34. Search the rest in openFDA.
Food and supplement recallsCovers FDA's Wed, Jul 29 (a week ago)1 touch MedGrid11
- Brooklyn Roasting Works LLCTouches MedGrid categories
Brooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box distributed between 04/01/2026 and 06/20/2026. — Ambient storage of the product may lead to Clostridium botulinum toxin formation.
- Green Jeeva LLC
Organic Moringa Powder; 15kg/bag (bulk); Product code: GJ96 — Moringa Powder ingredient positive for salmonella
- Man Fon, Inc.
Man Fon Inc. Won Ton Wrappers Extra Thin; Net Wt. 10 oz; UPC# 757168 977315, Keep Refrigerated, Can be Frozen. Sold in 48 units (10oz)/case. — Undeclared colors: Yellow#5, and Yellow#6.
- Man Fon, Inc.
Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers packed into "Wonton Noodles Net Wt. 5 LBS" plastic bags and sold as 10 units (4-lb bags)/… — No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
- Vintage Roots LLC
Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady, MT 59416. The product label declares: Ingredients: Filtered Water, Pu… — Unapproved food additive: sassafras bark.
- Modern Warrior Life, LLC
Modern Warrior Ready, Dietary Supplement, 60 CAPSULES — FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
- Shandong Ling Xian Food Co.,LTD
Island Pacific IMITATION CRAB FLAKES NET WT: 1.0 LB (454g) UPC: 0000000175012 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARC… — Undeclared sodium tripolyphosphate (STTP)
- Shandong Ling Xian Food Co.,LTD
Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARC… — Undeclared sodium tripolyphosphate (STTP)
- Total Nutrition Inc
1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams — Contaminated with Salmonella
- Shandong Ling Xian Food Co.,LTD
NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch,… — Undeclared sodium tripolyphosphate (STTP)
- GELLERT GLOBAL GROUP
Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Thaw… — Undeclared Allergen (Fish)
Device recallsCovers FDA's Wed, Jul 29 (a week ago)1 touch MedGrid47
- Medtronic NeurosurgeryTouches MedGrid categories
Ventriculostomy Kit, REF: 46154 — Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospin…
- Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 — Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve…
- Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter — Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- AVID Medical, Inc.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit. — Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
- Penumbra, Inc.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT — Due to manufacturing issues, reperfusion catheters may fractures
- Alphatec Spine, Inc.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System — Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication betwe…
- Medtronic MiniMed, Inc.
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) — For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This cou…
- Boston Scientific Corporation
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter — Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4) HIP… — The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- ICU Medical Inc.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flo… — ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
- Karl Storz Endoscopy
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. — Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
- Medline Industries, LP
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M — Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinar…
Showing 12 of 47. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Jul 22 (two weeks ago)11
- Tornier Perform Advanced Glenoid
Tornier, Inc.
- Anovo Surgical System (6Ne)
Momentis Surgical , Ltd.
- STEDI Scan Device
Stroke DX
- NanoZoomer S540MD Slide Scanner System
Hamamatsu Photonics K.K.
- PreludeSYNC Radial Compression Device
Merit Medical Systems, Inc.
- Lancet
Tianjin Huahong Technology Co., Ltd.
- AlphaTriPart - Monopolar MIC Instruments
Gimmi GmbH
- Lapidus Screw Kit
Relja Innovations, LLC
- Ossiclear (Ossiclear System)
Sounduct
- Op.n Spine Navigation and Robotic Guidance
Ecential Robotics
- E3D-C Interbody System
Evolution Spine
Label changesCovers FDA's Wed, Jul 22 (two weeks ago)7 touch MedGrid146
- Numbing Pain ReliefTouches MedGrid categories
Walgreen Company
- Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleTouches MedGrid categories
The Procter & Gamble Manufacturing Company
- Pain Relief Patch LidocaineTouches MedGrid categories
HyVee
- True Coast SPF 50 Mineral SunscreenTouches MedGrid categories
Foshan Sugar Max Cosmetics CO.,Ltd
- EarBalance Ear Pain DropsTouches MedGrid categories
Marie's Original Formulas LLC
- EarBalance Ear Pain DropsTouches MedGrid categories
Marie's Original Formulas LLC
- Lidocaine hydrochlorideTouches MedGrid categories
Medical Purchasing Solutions, LLC
- Colgate Max Fresh Cool Mint
Colgate-Palmolive Company
- Ampicillin and Sulbactam
Meitheal Pharmaceuticals Inc.
- Dove
Conopco, Inc. d/b/a Unilever
- MERCAPTOPURINE
Hikma Pharmaceuticals USA Inc.
- LUCEMYRA
BioCorRx Pharmaceuticals Inc
Showing 12 of 146. 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.