The FDA Let Substandard Factories Ship These Medications to the U.S.

Published: Tuesday, August 12, 2025 at 9:05 am

FDA Allowed Substandard Foreign Factories to Ship Drugs to the US Despite Bans

For over a decade, the Food and Drug Administration permitted substandard foreign factories to continue shipping medications to the United States, even after officially banning them due to dangerous manufacturing failures. This practice, largely hidden from the public, was exposed by ProPublica. The FDA stated these exemptions were necessary to prevent drug shortages, with safeguards like extra testing in place to ensure product safety.

ProPublica has published a list of over 150 exempted products, primarily from factories in India, with a few from China and Hungary. The list includes the names of drugs or ingredients exempted since 2013 and the manufacturers. While most factories are no longer banned, some remain so, yet are still allowed to send exempted drugs to the US.

The FDA did not regularly test the drugs or proactively monitor reports of adverse reactions. Drug safety experts emphasize the need for further study to determine if consumers were harmed. ProPublica compiled the list using historical records and data from a regulatory intelligence company. The list is current as of August 4th, and the FDA can add or remove drugs at any time.

ProPublica reached out to the drugmakers listed. Most did not respond. Some companies stated they had taken corrective actions, hired consultants, and invested in upgrades. Several factories are no longer banned, while others remain banned with or without exemptions.

BNN's Perspective:

This investigation raises serious questions about the FDA's oversight and prioritization of drug safety. While the agency cites the need to prevent drug shortages, the practice of allowing potentially substandard medications into the country warrants increased scrutiny. The lack of transparency and proactive monitoring is concerning. The FDA should consider a more robust system of testing and reporting to ensure the safety of the American public.

Keywords: FDA, drugs, import ban, substandard factories, drug shortages, exemptions, manufacturing failures, ProPublica, drug safety, medications, foreign factories, India, China, Hungary, testing, adverse reactions, drugmakers

Full Story