Infants' Tylenol medication recalled by McNeil after dosing-system complaints

More than a half million bottles of Infants' Tylenol Oral Suspension, 1 oz. grape, have been recalled voluntarily by McNeil Consumer Healthcare because of complaints about using the dosing system, the company announced.

The recall involves 7 lots at the wholesale and retail levels, approximately 574,000 bottles total. For a full recall list, click here. The recalled lot numbers are BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00 and the UPC code is 300450122308.

Infants' Tylenol is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.

McNeil said it has received a small number of 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 aged 2 years and older and remain available.

No adverse events associated with this action have been reported to date, the company said, and the risk of a serious adverse medical event is remote. Consumers can continue to use Infants' Tylenol provided the flow restrictor at the top of the bottle remains in place. The company discussed how to use the product's dosing system in a separate message to consumers also issued today.

If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Consumers can request a refund by visiting the company’s website or by contacting McNeil at (888) 222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Further information is also available at the website.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-332-1088.