Johnson & Johnson's McNeil unit recalled children's Tylenol and paid a $25 million fine

In 2009 and 2010, Johnson & Johnson's McNeil Consumer Healthcare unit issued multiple recalls of Tylenol, Motrin, Benadryl and other over-the-counter medicines. Problems included bacterial contamination at the Fort Washington, Pennsylvania plant, metal particles in liquid medicines, and a musty odour linked to contaminated pallets.

FDA inspections revealed widespread violations of good manufacturing practice, including inadequate testing, unsanitary conditions and failure to investigate consumer complaints. In March 2011, the FDA and Justice Department filed a consent decree requiring McNeil to bring three plants into compliance before resuming production.

In 2015, McNeil agreed to pay $25 million to resolve a U.S. Department of Justice investigation into the recalls. The settlement covered felony charges related to shipping adulterated drugs. By then, the Tylenol brand had suffered lasting reputational damage in a market it once dominated.

Johnson & Johnson overhauled quality leadership and invested in manufacturing controls. The case is often contrasted with the company's 1982 Tylenol tampering response: the same brand, but a self-inflicted rather than externally caused crisis.