Silvestri Sweets Issues Voluntary Allergy Alert on Undeclared Pecan and Wheat in Cookie Butter Holiday Bark and Pecan, Cranberry & Cinnamon Holiday Bark

Compounders sometimes produce drugs using bulk drug substances or active pharmaceutical ingredients. Because compounding from these substances presents risks to patients, sections 503A and 503B of the FD&C Act place limits on the bulk drug substances that can be used in compounding.

Middlefield, OH 9/5/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6 oz. and 1.25 lb. packages, one lot of Organic Gouda Cheese in 8 oz. packages, and specific lots of Mozzarella/P

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.

Sato Pharmaceutical Co., Ltd. – 11/21/2025. Country: Japan. Record Type: 483

Meeting Presentations. CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users fees, to drug advertising and marketing, to genomics, to over-the-co