U.S. Food and Drug Administration Press Releases

• Published on August 29, 2025 - 20:22 GMT

  

  July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting ...

  Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr)   Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information…

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 29, 2025 - 16:20 GMT

  

  Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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• Published on August 29, 2025 - 00:20 GMT

  

  DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination

  Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety - Potential Burkholderia cepacian contamination Company Name: DermaRite …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 28, 2025 - 20:21 GMT

  

  Aquastar (USA) Corp Recalls Kroger Mercado Frozen Cooked Shrimp Because of Possible Health Risk

  Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Potential Contaminant – cesium-137 (Cs-137) Company Name: …

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• Published on August 28, 2025 - 20:21 GMT

  

  Aquastar (USA) Corp Recalls Cocktail Shrimp 6oz Because of Possible Health Risk

  Summary Company Announcement Date: August 28, 2025 FDA Publish Date: August 28, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Potential Contaminant – cesium-137 (Cs-137) Company Name: …

  Distribution channels: Food & Beverage Industry
• Published on August 28, 2025 - 19:34 GMT

  

  FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)

  During routine pharmacovigilance, FDA identified six fatal cases of amyloid related imaging abnormalities with edema (ARIA-E) early in treatment. These fatalities prompted an in-depth analysis of serious and fatal outcomes of ARIA-E occurring prior to the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 27, 2025 - 22:33 GMT

  

  Country Eggs, LLC Recalls Large Brown Cage Free “Sunshine Yolks” Because of Possible Health Risk

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 27, 2025 - 21:33 GMT

  

  Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to ...

  Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) …

  Distribution channels: Food & Beverage Industry
• Published on August 27, 2025 - 17:32 GMT

  

  FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine

  Clozapine is an atypical antipsychotic medicine used to treat people who are severely ill with schizophrenia who remain symptomatic on other schizophrenia medicines. Clozapine is thought to work by balancing the brain’s levels of dopamine and serotonin, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 27, 2025 - 17:32 GMT

  

  FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events

  [8/27/2025] FDA's Center for Drug Evaluation and Research, Office of New Drugs has accepted a Letter of Intent for the qualification of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a reasonably likely surrogate endpoint …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 27, 2025 - 07:52 GMT

  

  Company Voluntarily Recalls Honey Balsamic Salad Kit Due to Potential Undeclared Sesame and Soy

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 27, 2025 - 01:11 GMT

  

  Platinum Biologics LLC - 705090 - 08/15/2025

  Delivery Method: Via UPS and EMAIL Reference #: CBER 25-705090 Product: Biologics Recipient: Recipient Name Beeben Russell Recipient Title Chairman of the Board Platinum Biologics LLC 1510 E Colonial Drive, Suite 103 Orlando, FL 32803 United States support …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 27, 2025 - 01:10 GMT

  

  Innate Healthcare Institute - 695592 - 08/15/2025

  Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-695592 Product: Biologics Recipient: Recipient Name Travis Whitney, NMD, DAASCP, MSc, MSAc Recipient Title Founder and Chief Medical Officer Innate Healthcare Institute 4835 East Cactus Road …

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• Published on August 26, 2025 - 21:15 GMT

  

  PAIN FLEX may be harmful due to hidden drug ingredients

  [8-22-2025] The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores. FDA laboratory analysis confirmed …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 26, 2025 - 14:20 GMT

  

  AlzClipp / UniUni - 711274 - 07/29/2025

  Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 29, 2025 RE: 711274 Dear AlzClipp: This letter is to advise you that the United States Food and Drug Administration ( …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 26, 2025 - 02:48 GMT

  

  Viva Raw Issues Voluntary Recall of Two Lots of Dog an Cat Foods Due to Salmonella and Listeria Monocytogenes Contamination

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 25, 2025 - 16:39 GMT

  

  FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

  AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics UPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 25, 2025 - 16:39 GMT

  

  Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting - 09/24/2025

  On This Page Date: September 24, 2025 Time: 9:00 a.m. - 12:00 p.m. ET The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment.…

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 25, 2025 - 15:20 GMT

  

  Guidance Documents for Drug Applications

  Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 25, 2025 - 15:20 GMT

  

  Development & Approval Process | Drugs

  Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER). The center's …

  Distribution channels: Healthcare & Pharmaceuticals Industry