Recent News

The Missouri Department of Health and Senior Services received the following news release regarding seven lots, approximately 574,000 bottles, of Infants' TYLENOL Oral Suspension, 1 oz. Grape. The item was distributed nationwide.

The full recall product list is:

The recall was initiated after receiving a small number of complaints from consumers who reported difficulty using the Infants' TYLENOL SimpleMeasure dosing system.

No adverse events associated with this action have been reported to date 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. If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product.

Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

• Online: www.fda.gov/medwatch/report.htm⁵
• Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm⁶. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178.

The full recall can be found at www.fda.gov/Safety/Recalls/ucm292537.htm?source=govdelivery.