FDA WARNING_LETTER - www.bigpharmausa.com - June 04, 2025

On June 4, 2025, the FDA issued a Warning Letter to www.bigpharmausa.com for unlawfully selling unapproved and misbranded opioid drugs, specifically "Generic Tramadol 200 mg" and "Generic Oxycodone 20 mg," to U.S. consumers via their website.

The FDA's review found that the website introduces unapproved new drugs into interstate commerce, violating sections 301(d) and 505(a) of the FD&C Act. These products are considered new drugs because they are not generally recognized as safe and effective for their labeled uses and lack FDA approval. The letter highlights that while FDA-approved versions of tramadol and oxycodone exist, the products offered by www.bigpharmausa.com do not have approved applications.

Furthermore, the drugs are misbranded under sections 301(a), 502(f)(1), 503(b)(1), and 301(k) of the FD&C Act. They lack adequate directions for use, as they are prescription drugs intended for conditions not amenable to self-diagnosis and treatment by a layperson. Additionally, www.bigpharmausa.com offers these prescription drugs without requiring a prescription, jeopardizing patient safety.

The FDA emphasized the significant public health risks associated with purchasing unapproved and misbranded opioids, including contamination, counterfeiting, and varying