McNeil Consumer Healthcare, the Johnson & Johnson subsidiary that makes Tylenol, issued recalls of infants' and children's liquid Tylenol in September 2009, because certain product lots failed to meet internal testing standards, according to United Press International. McNeil knew foreign particles were in the products in May 2009. In March 2015, McNeil-PPC Inc. pleaded guilty to one misdemeanor count of delivering impure infants' and children's nonprescription liquids into interstate commerce and agreed to pay fines and forfeits of $25 million.
The September 2009 Tylenol recall covered children's and infants' Tylenol liquid that McNeil produced between April and June 2009, reports United Press International. In May 2009, customers began notifying the company that particles were floating in the liquid products. McNeil delayed taking corrective or preventive action for months after consumers had made complaints. Investigation revealed the particles were tiny metal pieces that the company said did not create consumer safety or health risks.
After the recall, the U.S. Food and Drug Administration investigated the Fort Washington, Pennsylvania, manufacturing plant and determined that the manufacturing processes violated the federal Food, Drug and Cosmetic Act, notes United Press International. The recall affected tens of thousands of bottles of the over-the-counter medication the Johnson & Johnson subsidiary had produced. The U.S. Department of Justice prosecuted the company in federal district court.