ALERT: New FDA Warning Letter to www.thesafepills.org
This is a reprint of an FDA warning letter posted March 27, 2025 to www.thesafepills.org.
Summary:
Issued: March 27, 2025
Website Name: www.thesafepills.org
Reason for Warning: Sale of unapproved and misbranded opioid medications (Tapentadol)
Drugs Involved: Aspadol 100mg, Typendol 100mg, Generic Nucynta
Risk Statement: FDA observed that www.thesafepills.org introduces into interstate commerce the opioid tapentadol. The website sells unapproved and misbranded drugs without FDA approval, required labeling, or prescription oversight. These drugs may be counterfeit, contaminated, or incorrectly dosed, posing serious risks such as addiction, respiratory depression, overdose, and death.
The U.S. Food and Drug Administration (FDA) warned the operators of www.thesafepills.org, an online pharmacy based in Singapore, for marketing and selling unapproved and misbranded opioid drugs to U.S. consumers. The warning, dated March 27, 2025, outlines serious violations of federal law and underscores the public health dangers associated with unregulated pharmaceutical sales.
According to the FDA, www.thesafepills.org has been offering tapentadol under various product names, including Aspadol 100mg, Typendol 100mg, and generic Nucynta. These products are being sold without a valid prescription and lack FDA approval, which is required for any drug marketed for use in the United States.
Tapentadol is a controlled substance available in the U.S. only through a prescription and under strict regulatory oversight. There are two FDA-approved formulations, NUCYNTA and NUCYNTA ER, which must carry a boxed warning, or “black box warning,” alerting consumers to the risks of addiction, life-threatening respiratory depression, and fatal interactions with alcohol or other central nervous system depressants.
The products sold by www.thesafepills.org lack essential labeling and safety warnings. They may also be counterfeit, improperly formulated, or contaminated—further endangering consumers who purchase and use them.
In addition to selling unapproved drugs, the website is in violation of laws that prohibit the sale of prescription drugs without a valid prescription. This not only places consumers at risk but also constitutes misbranding under the Federal Food, Drug, and Cosmetic Act.
The FDA has demanded that the site immediately cease the sale of all unapproved and misbranded drugs to U.S. consumers. Failure to comply may result in legal action, including product seizures and injunctions. Consumers are strongly urged not to purchase medications from www.thesafepills.org or any unverified online pharmacy. Anyone who has used these products should consult a healthcare provider immediately and report any adverse reactions to the FDA through the MedWatch Adverse Event Reporting Program.
This warning serves as a critical reminder of the dangers associated with purchasing prescription medications outside of regulated medical channels. The FDA continues to monitor and take enforcement action against online pharmacies that compromise consumer safety.