FDA WARNING_LETTER - www.d-pharmacy.com - July 29, 2025

The FDA issued a warning letter to D-Pharmacy, operating via the website www.d-pharmacy.com, on July 16, 2025, following an inspection that revealed significant regulatory violations. The inspection identified that the company was selling unapproved and misbranded drugs, including opioids, benzodiazepines, and Schedule II stimulants, to U.S. consumers over the internet. These actions violate sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA highlighted the public health risks associated with the easy availability of these substances online, particularly given the ongoing opioid crisis and the potential for abuse and severe health outcomes associated with benzodiazepines and stimulants. The agency noted that these drugs, marketed under various names such as "Aspadol (Tapentadol)" and "Hydrocodone 10/325mg," lack FDA approval and do not meet safety and efficacy standards.

The FDA has mandated that D-Pharmacy cease the sale of these unapproved and misbranded drugs to U.S. consumers immediately. The agency emphasized the critical nature of this action to protect public health and prevent potential harm from drugs that may be contaminated, counterfeit, or improperly labeled. The letter serves as a formal notice for D-Pharmacy to comply with FDA regulations and halt the unlawful sale of these products.