The Food and Drug Administration has issued a warning against purchasing Accutane online, especially for pregnant women and girls.
It's set up a new Web site to warn the public of the potential risks.
Hazards from the acne treatment reportedly include birth defects, miscarriage, premature births and infant mortality.
The FDA also warns of possible side effects such as headaches, blurred vision, dizziness, nausea, and stroke.
Accutane is produce by Swiss drug maker Roche Holding.
The drug giant released a statement, saying Accutane should only be purchased through its legal distributor I-Pledge.