For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

This page outlines the deferral requests and advice letters issued by FDA to manufacturers of over-the-counter (OTC) topical antiseptic products. These products are categorized as either consumer or health care and they include rubs and washes.

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

Baltic, OH (Dec. 4, 2025) – Lil’ Turtles is recalling all lots of its Grandma Belle’s Tomato Basil Soup for misbranding due to the milk allergen not being declared on the label. The Grandma Belle’s Tomato Basil Soup was packaged in 17 oz glass jars.

FDA is requiring new warnings about the risk of serious breathing difficulties that can lead to death in patients who use gabapentanoids with opioid pain medicines or other drugs that depress the central nervous system.

Unapproved New Drugs