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FDA Warns Companies Selling Fake Accutane

Donna Young

The Food and Drug Administration (FDA) on Tuesday warned Internet companies in California, Colorado, Florida, Oregon, and Canada to cease illegal sales of unapproved isotretinoin products that are advertised as Accutane on the companies' Web sites.

Accutane is Roche Pharmaceutical's FDA-approved brand name for isotretinoin.

The product was approved in 1982 to treat severe recalcitrant nodular acne and is known to cause severe birth defects and spontaneous abortion.

Under Roches' FDA-approved System to Manage Accutane Related Teratogenicity risk management program, only certain physicians may legally prescribe the drug, and prescriptions must be filled within seven days and bear a yellow sticker certifying the patient is not pregnant.

Patients are also required to sign a consent form attesting that they are aware of the risks associated with Accutane.

One California company, through its Web sites and, is selling products advertised as "Accutane topical gel," according to FDA.

The products shipped to the United States are labeled as "ISOTREX ISOTRENINOINA GEL 0.05%" and the labeling is in Spanish, the agency said. 

The company sells the products to U.S. consumers without a prescription, FDA added. The orders are filled by a Mexican pharmacy.

Two Oregon companies—Today's Business and Medicine-Mexico, through the Web site—are also selling the unapproved and misbranded "Accutane topical gel" product labeled in Spanish.

FDA warned Canadian company Smart Med Pharmasave that it was illegally shipping to U.S. consumers unapproved "Accutane Roche 40" capsules labeled as containing 40 mg of isotretinoin.

The product is advertised on as Accutane, according to FDA.

A Florida company was selling a product labeled as "Roaccutane Isotretinoin 10 mg tablet" on its Web site

The orders for the product were filled by a pharmacy in Thailand, FDA said.

A Colorado company was selling a similarly labeled capsule product on three Web sites:,, and Those "Roaccutane" orders were also filled by a Thai pharmacy, the agency said.

FDA gave the companies 15 days to respond to the agency in writing describing "the actions you are taking to assure that your operations are in full compliance with United States law."