What’s really in
Over-the-counter meds

In the United States, over-the-counter (OTC) medications are widely trusted for their accessibility, affordability, and efficacy. However, recent developments have raised concerns about the safety and oversight of these commonly used drugs.

You might remember the 2020 recall of Zantac, the heartburn medicine. In 2020, the FDA requested the removal of all ranitidine (Zantac) products from the market after laboratory tests found that levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, could increase over time and when stored at higher temperatures. This discovery led to widespread recalls and legal actions, with over 70,000 lawsuits proceeding against former manufacturers.

And this problem with oversight is amplified when we look at over-the-counter medicines produced in other countries and imported to the U.S.

One notable case is the March 2025 recall of nearly 40 generic medications manufactured by Glenmark Pharmaceuticals in India. The U.S. Food and Drug Administration (FDA) issued a Class II recall due to violations of current good manufacturing practices (CGMP). Class II means the use of these products could cause temporary or medically reversible adverse health consequences, with the probability of serious consequences being remote. These medications, used to treat conditions such as high blood pressure, high cholesterol, seizures, and allergies, were distributed nationwide, including through major retailers like Amazon and Walmart. The FDA’s inspection of the facility revealed lapses in cleaning procedures and testing protocols, which are essential for ensuring the quality and safety of pharmaceutical products. The recall encompassed 148 lots of tablets and capsules produced between 2021 and 2023. The recall highlights deficiencies in Glenmark’s quality control systems, raising questions about the safety of generic drugs produced overseas.

The FDA’s oversight of foreign drug manufacturing facilities has faced challenges, particularly during the COVID-19 pandemic.

In 2022, the FDA inspected only 6% of overseas plants where drugs and their ingredients are produced, a stark decrease from the 37% inspection rate in 2019. This decline has raised concerns about the quality and safety of imported medications. The FDA employs a risk-based site selection model to prioritize facilities for inspection, focusing on those that pose the greatest potential risk to public health. However, resource constraints and travel restrictions have hindered the agency’s ability to conduct timely inspections. Once drugs arrive in the United States, the FDA reviews some shipments to determine their admissibility. It’s important to note that while the FDA does test samples of imported drugs, the vast majority of imported shipments are not tested.

The challenges faced by the FDA in inspecting foreign drug manufacturing facilities highlight the need for enhanced resources and strategies to safeguard the U.S. drug supply. Ensuring the quality and safety of imported medications is crucial for protecting public health and maintaining trust in the healthcare system.

And here is what is more concerning.

The majority of our over-the-counter medications are not produced in the United States. In fact, 80% of the generic drugs consumed in the U.S. are manufactured overseas, with a significant portion coming from countries like India and one of our biggest adversaries – China.