Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused by bacteria – and none caused by viruses. Learn to safely use...
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.
Babcock Dairy of Madison, Wisconsin, is voluntarily expanding its recall on Orange Custard Chocolate Chip ice cream that may be labeled as Chocolate Peanut Butter. People who have an allergy or severe sensitivity to eggs run the risk of...
Patients today have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.
From blood to vaccines, FDA protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. Read these Consumer Updates to learn more.
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on the clinical use of integration site analysis (ISA) during long term follow-up...
MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA laboratory analysis confirmed that Umary contains diclofenac and...
IHA Beverage of Commerce, CA is recalling Super Cinnamon Powder 4oz, because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is...
Endo USA, Inc. is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.
Fabalish Inc, Carlstadt, NJ is recalling Kickin’ Carrot Falafel Bites because it may be contaminated with Shiga toxin-producing Escherichia coli (E. coli) O121:H19
Grimmway Farms has issued a recall of select organic whole carrots and organic baby carrots that should no longer be in grocery stores but may be in consumers' refrigerators or freezers.
FDA Approves Kebilidi, an adeno-associated virus vector-based gene therapy indicated for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 03/01/2024 Short Title (70 char) IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 03/01/2024 FEI Number 3014483112 Firm Name...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 07/02/2024 Short Title (70 char) US Specialty Formulations LLC. Allentown, PA. 483 issued 07/02/2024 FEI Number 3010680515 Firm Name US Specialty...
Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling two lots of Bowl & Basket Onion Soup Mix, UPC 41190-08394 at the consumer level because it may contain undeclared egg. People who have an...
FDA is proposing to end the use of oral phenylephrine as an active ingredient from OTC Monograph M012 for the temporary relief of nasal congestion because the agency determined it is not effective.
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 10/04/2024 Short Title (70 char) Avenue Pharmacy Inc dba Pathway Pharmacy. Ocala, FL. 483 issued 10/04/2024 FEI Number 3010810839 Firm Name Avenue...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 09/27/2024 Short Title (70 char) Brookfield Medical Surgical Supply Inc. Brookfield, CT. Untitled Letter issued 09/27/2024 FEI Number 3011430551...
Use or consumption of products contaminated with Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 09/18/2024 Short Title (70 char) Staska Pharmaceuticals, Inc. Bennett, NE. 483 issued 09/18/2024 FEI Number 3017473850 Firm Name Staska...
Babcock Dairy of Madison, Wisconsin, is voluntarily recalling approximately 41 cases of Orange Custard Chocolate Chip ice cream that may be labeled as Chocolate Peanut Butter. People who have an allergy or severe sensitivity to eggs or...
The Food and Drug Administration is advising consumers not to purchase or use Umary, a product promoted and sold for pain on various websites, including https://www.solovital.com and possibly in some retail stores.
Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes...
Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Casules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with...
Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. VitalityXtra was found to be...
Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes...