US FDA

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

Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse

Salinas, Calif., August 26, 2025 – In response to a recall initiated by Latitude 36 Foods, LLC., Taylor Fresh Foods is voluntarily recalling the Taylor Farms Honey Balsamic Salad Kit 6/8.3oz. because it may contain undeclared sesame and soy allergens. People who have an allergy or severe sensitivity

FDA hosted its fourth summit on June 8, 2023, as an integral part of FDA’s overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential.

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.

Citalopram (marketed as Celexa) Information

How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?

Learn how the FDA regulates drugs using science and data to ensure their safety, quality and efficacy. FDA plays a vital role in drug development and approval process. Watch our informative video series on FDA drugs, FDA approval, and the drug development process.

FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professi

Unapproved New Drugs/Misbranded

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.

August 25, 2025 – Viva Raw LLC, Charlotte, NC is voluntarily recalling two lots of dog and cat foods due to contamination with Salmonella and Listeria monocytogenes. The recall is for Lot 21495 (Viva Ground Beef for Dogs; Viva Beef & Turkey for Puppies) and Lot 21975 (Viva Ground Chicken for Dogs;