Recipient: Estaderma South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER November 3, 2025 Estaderma: This is to advise you that the United States (U.S.) Food and Drug …
Recipient: AceCosm Hong Kong SAR China Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 AceCosm: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently …
Recipient: Dermax Co., Ltd China Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Dermax Co., Ltd.: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently …
Recipient: Glow Nest Beauty United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Glow Nest Beauty: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) …
Recipient: Aesthetic Essentials Limited Hong Kong SAR China Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Aesthetic Essentials Limited: This is to advise you that the United States (U.S.) Food …
Recipient: Cosmenic Panama Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER November 3, 2025 Cosmenic: This is to advise you that the United States (U.S.) Food and Drug Administration ( …
Recipient: Elle Pharm United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Elle Pharm: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently …
Recipient: Dermacare dba Filler Outlet South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER November 3, 2025 Dermacare dba Filler Outlet: This is to advise you that the United …
Recipient: Korean Aesthetic dba Korean Fillers United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Korean Aesthetic dba Korean Fillers: This is to advise you that the United States (U.S …
Recipient: Maypharm South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices WARNING LETTER November 3, 2025 Maypharm: This is to advise you that the United States (U.S.) Food and Drug …
Action The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation (IBS-C). Linzess is the first treatment approved for IBS-C in pediatric …
May 9, 2025 Safety Communication The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are recommending a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while the …
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 Summary Company …
For Immediate Release: September 05, 2025 The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of …
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 Summary Company …
For Immediate Release: May 09, 2025 Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and …
[9-5-2025] The Food and Drug Administration is advising consumers not to purchase or use FTX PLUS, a product promoted and sold for joint pain on various websites, including walmart.com and possibly in some retail stores. FDA laboratory analysis confirmed …
[9-5-2025] The Food and Drug Administration is advising consumers not to purchase or use REUMA KING, a product promoted and sold for joint pain on various websites, including ebay.com and possibly in some retail stores. FDA laboratory analysis confirmed …
Image Español People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of …
For Immediate Release: May 09, 2025 The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food. The FDA …
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