The medications were recalled due to manufacturing deficiencies, not adverse health reactions, but consumers have been advised to stop taking them.
McNeil Consumer Healthcare, a unit of Johnson & Johnson, has voluntarily recalled certain lots of infants’ and children’s over the counter (OTC) liquid medicines because of manufacturing deficiencies.
Although none of the products were recalled because of adverse health reactions, McNeil has advised individuals to stop taking them. Specifically, the recall involves all unexpired lots of seven products in 43 different flavors and sizes, including Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Infants’ Motrin Drops, Children’s Zyrtec liquids in bottles, and Children’s Benadryl Allergy liquids. The lots were recalled because they may contain more of the active drug ingredient than specified, while other products that were recalled may contain foreign particles or inactive ingredients that may not meet testing requirements.
According to McNeil spokesman Marc Boston, “The particles may be solidified product ingredients or manufacturing residue such as tiny metal specks.” A full list of recalled products was put together by McNeill and made available here. Individuals can also call the company hotline at (888) 222-6036.
The action was prompted by the results of a routine inspection at a company facility in Fort Washington, PA on Friday, April 30. The company was cited for manufacturing violations, according to the FDA. McNeil is now “conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made,” according to the FDA release.
This is the second major recall for McNeil this year. In January, the company recalled several hundred lots of adult and children’s products, including certain lots of Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin, and Tylenol because of reports of moldy smells emanating from OTC medications made at a plant in Puerto Rico.