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Hydroquinone is a skin bleaching ingredient used to lighten areas of darkened skin. In 1982, the FDA published a rule to propose that OTC skin bleaching drug products containing 1.5 to 2 percent hydroquinone be generally recognized as safe and effective (GRASE). In 2006 research revealed that hydroquinone taken orally by mice or rats could cause cancer. It also has been linked with a medical condition in humans known as ochronosis (skin darkening and disfiguration) when applied topically.At that time the FDA requested more scientific testing on hydroquinone. Those tests began in 2009. On 11/17/10 the FDA recalled specific batches of Triluma, "Firm was notified by supplier of a subpotent active ingredient". That is not the same as a complete ban and the product can still be used. It contains 4% hydroquinone and therefore requires a prescription.