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How Muscle Toxicity, Drug Interactions, and Design Blind Spots Led to a Global Withdrawal In 2001, Bayer withdrew cerivastatin—marketed as Baycol in the U.S. and Lipobay internationally—after mounting reports of rhabdomyolysis, a severe form of muscle breakdown that can lead to acute renal failure and death. The consequences were immediate and severe: a global recall, thousands of adverse event reports, over 50 confirmed deaths, multibillion-dollar litigation settlements, and long-term reputational damage that weighed heavily on Bayer’s valuation for years.

The FDA has announced a nationwide recall of a widely used over-the-counter nasal spray after testing revealed contamination with pathogenic bacteria capable of causing serious infections. […]

According to MDLinx, Rofecoxib (Vioxx) — Merck’s blockbuster COX-2 selective anti-inflammatory drug — was withdrawn in 2004 after long-term clinical data revealed a significant increase in heart attack and stroke risk. This single mechanistic toxicology failure erased more than $30 billion in market value, triggered historic litigation, and permanently reshaped FDA’s cardiovascular risk requirements.

How Troglitazone’s Hepatotoxicity Changed Drug Development Forever — and Why It Still Matters Today Troglitazone (Rezulin), introduced by Warner-Lambert and later absorbed by Pfizer, was once celebrated as a breakthrough insulin-sensitizing therapy for type 2 diabetes. Within a few years, it became one of the most catastrophic toxicology failures in FDA history — linked to idiosyncratic yet sometimes fatal liver injury, multiple cases of acute liver failure, and a full U.S. market withdrawal in 2000.