FDA WARNING_LETTER - www.plakini-pharma.com - July 29, 2025

The FDA issued a warning letter to Plakini Pharma on July 16, 2025, following an inspection of their website, www.plakini-pharma.com. The inspection revealed 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), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations include the sale of unapproved opioids such as fentanyl, hydrocodone, and tramadol, which pose significant public health risks due to their potential for abuse and the ongoing opioid crisis. Additionally, the sale of unapproved benzodiazepines and Schedule II stimulants raises concerns due to their high potential for abuse and the associated risks of polysubstance use.

The FDA emphasized that these unapproved drugs do not meet the safety and efficacy standards required for FDA-approved medications, posing risks of contamination, counterfeit ingredients, and incorrect dosages. The agency has demanded that Plakini Pharma immediately cease the sale of these unapproved and misbranded drugs to protect U.S. consumers from potential harm.

The FDA"s actions are part of broader efforts to address the public health impacts of drug abuse and ensure that all drugs sold in the U.S. comply with regulatory standards. Plakini Pharma is required to comply with FDA regulations and halt the unlawful sale of these drugs to avoid further enforcement actions.