Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination

Voluntary recalls of acne products after FDA testing finds small number of proudcts with elevated levels of benzene

FDA Roundup: March 11, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Office of Generic Drugs | Offices and Divisions

Generic Drugs Offices and Divisions

Zhejiang Tianyu Pharmaceutical Co Ltd – 631054 – 02/28/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Zhejiang Tianyu Pharmaceutical Co., Ltd. – 631054 – 08/17/2022

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Orange Book Data Files

Data Descriptions updated (February 24, 2017)

Natuzen Co., Ltd. – 677942 – 03/03/2025

CGMP/Finished Pharmaceuticals/Adulterated

Natuzen Co., Ltd. – 677942 – 05/03/2024

CGMP/Finished Pharmaceuticals/Adulterated

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT-…

Patent Certifications and Suitability Petitions

Information on patents and suitability petitions that impact the availability of generic drugs.