McNeil Announces Recall of Infant Tylenol Due to Dosing System Complaints

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. (“McNeil”), is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants’ Tylenol Oral Suspension, 1 oz. Grape distributed nationwide in the United States. Infants’ Tylenol is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.


McNeil is initiating this recall as a precaution after receiving complaints from consumers who reported difficulty using the Infants’ Tylenol SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe. Children’s Tylenol products are intended for children two years of age and older and remain available.


Consumers can continue to use Infants’ Tylenol provided the flow restrictor at the top of the bottle remains in place. If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product.


See the FDA Alert