US Food and Drug Administration
@usfda
Announcements from the US Food and Drug Administartion. Not an official account!
Recall of “Tippy Toes” Apple Pear Banana Baby Food Due to Elevated Patulin Levels...
Counterfeit Green Lumber products contain undeclared tadalafil, posing serious health risks; verify packaging and report. ...
Green Lumber dietary supplement recalled for undeclared tadalafil...
Moringa capsules recalled nationwide over Salmonella risk; 7 illnesses, 3 hospitalizations linked. Check lot numbers from Feb 2025. ...
FDA issues warning to Shopaax.com for selling "Royal Honey for Him" containing undeclared sildenafil, violating FD&C Act regulations. ...
FDA issues warning to MKS Enterprise for selling honey containing undeclared tadalafil and making unapproved drug claims. ...
FDA warns Boner Bears Chocolate contains undeclared sildenafil, posing risks for those on nitrates; avoid use. ...
FDA warns DTF Sexual Chocolate contains undeclared sildenafil, tadalafil; risks dangerous interactions. ...
FDA warns Fantasy Aphrodisiac Chocolate contains undeclared sildenafil, posing risks for those on nitrates; avoid use. ...
FDA warns LOVION Chocolate with Ginseng for Men contains hidden sildenafil, tadalafil—risking dangerous interactions; avoid use. ...
Two new drugs approved in 2026 expand treatment options for rare and common conditions...
Electrical safety risks prompt recall of Medline homecare beds after reports of fires, injuries, and fatalities; follow updated use instructions. ...
FDA requests removal of cardiovascular, breast cancer, and dementia risks from HRT boxed warnings to improve informed decision-making...
FDA approves hormone therapies to ease menopausal symptoms; updates cover drug safety, recalls, and public health tips....
FDA emphasizes drug safety, recalls, and new therapies; highlights risks of SARMs, fentanyl patches, and unapproved products. ...
FDA continues CID Paired Meeting Program to advance innovative trial designs; up to 8 proposals annually for late-stage drug development. ...
FDA issues warning to Nutrishus Brands over unapproved drug claims and misbranded sugar products...
FDA removes boxed warnings on 6 menopausal hormone therapies to improve risk clarity and support informed women’s choices. ...
FDA sets new acceptable intake limits for nitrosamine impurities in drugs, updates implementation timelines, and enhances testing guidance. ...
FDA clarifies expanded access pathways for investigational drugs amid new statutory requirements...
Allergy alert: Undeclared milk and soy in Junebar snack bars prompts recall...
Recall of Wellsley Farms Atlantic Salmon at BJ’s due to Listeria risk...
FDA removes boxed warnings on 6 menopausal hormone therapies to improve risk clarity and support informed women’s choices. ...
FDA collaborates with public-private consortia to bridge science gaps in drug development, advancing regulatory tools and innovation. ...
FDA completes key PDUFA VI deliverables on drug safety, data standards, and stakeholder engagement; highlights progress in regulatory modernization. ...
Menopausal hormone therapies update with new prescribing info for Prometrium, Divigel, Cenestin, Enjuvia, Estring, and Bijuva...
FDA proposes removing cardiovascular, breast cancer, and probable dementia risks from menopausal hormone therapy Boxed Warnings to clarify benefit/risk profile. ...
FDA approves first portable device delivering electrical fields for pancreatic cancer treatment...
FDA enhances oversight of prescription stimulants amid rising use and overdose risks...
FDA finalizes guidance on antimicrobial use in food animals amid declining sales and increased surveillance efforts...
FDA extends EUAs for COVID-19 treatments including Pemgarda, Gohibic, Kineret, Lagevrio, Paxlovid, and Olumiant amid PHE expiration; existing authorizations remain in effect. ...
FDA warns Rhino Choco VIP Chocolate for Men contains undeclared tadalafil, posing serious health risks; avoid use. ...
FDA warns against ilum Male Sexual Enhancement Chocolate for hidden tadalafil; unsafe interactions with nitrates pose serious health risks. ...
FDA warns Pink Pussycat Aphrodisiac Chocolate contains undeclared tadalafil, risking dangerous interactions; avoid use. ...
FDA warns Boner Bears Chocolate Bars contain undeclared sildenafil, posing risks for consumers on nitrates or with cardiovascular conditions. ...
Warning: Multiple sexual enhancement and energy products may be harmful due to hidden drug ingredients. ...
Class I recall of Broselow Rainbow Tapes and ALS Organizers due to medication dosing errors...
FDA advances generic drug science with annual research priorities, public workshops, and awarded projects shaping regulatory innovation....
FDA launches Compounding Quality Center of Excellence to enhance compounded drug standards...
FDA Compounding Quality Center of Excellence annual conference open to stakeholders...
FDA emphasizes use of Bayesian methods, adaptive designs, and real-world data to accelerate drug development and regulatory decisions. ...
FDA launches third-year QMM assessment program for drug manufacturers to enhance quality practices and supply chain resilience...
FDA releases new condition-specific patient experience reports and meeting summaries, including pending reports for rare diseases. ...
FDA announces upcoming externally-led PFDD meetings across multiple rare and complex diseases through 2026...
FDA releases draft guidance on certification process for designated medical gases...
FDA advances regulatory framework for AI, continuous, and distributed manufacturing in drug industry...
FDA issues warning to ProDx Health for marketing HIV self-collection kits without approval...
FDA approves pembrolizumab with paclitaxel for platinum-resistant ovarian cancer...
FDA issues warning to Boothwyn Pharmacy for sterile compounding violations and adulterated drug products...
FDA advances drug safety and innovation through new scientific tools and standards...