McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

Last week, the FDA and McNeil Consumer Healthcare launched a massive voluntary recall of certain medications for infants and children.  There is a dedicated McNeil website that addresses the recalls.  In addition, the FDA has published a press release that has some of the important information regarding the recall

The following is some basic information concerning the recall, as published by McNeil under the Product Recall Information:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The investigation into these products, which include, but are not limited to, Infants’ and Children’s Tylenol and Motrin (Please click here for a complete listing) is ongoing.  The Commissioner of Food and Drugs, Dr. Margaret A. Hamburg, states:  “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

We will continue to monitor this massive recall.  Please immediately check your homes for the recalled products. We strongly recommend that you read and follow the FDA’s instructions.