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On August 8, 2001 Bayer AG (the German-based manufacturer of Baycol) voluntarily recalled Baycol from the US market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction. Baycol (cerivastatin) was initially approved in the US in 1997 and is a member of a class of cholesterol-lowering drugs commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol.

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. As of August 8, 2001, the US Food and Drug Administration (FDA) had received reports of 31 US deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

Individual and class action lawsuits have been filed in connection with injuries caused by Baycol.