Johnson & Johnson’s McNeil Consumer Healthcare division is recalling about 574,000 1 oz. bottles of grape-flavored Infants’ Tylenol.
McNeil is recalling the over-the-counter medication as a precaution after receiving a small number of complaints from consumers who reported difficulty using the Infants Tylenol's "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 correct dose. In some cases, the flow restrictor was pushed into the bottle when the syringe was inserted.
No injuries have been reported, and the risk of a medical event is remote, McNeil said in a statement. Consumers can continue to use Infants’ Tylenol if the flow restrictor at the top of the bottle is in place.
If the flow restrictor is pushed into the bottle, the parent or caregiver shouldn’t use the medication.
Consumers can request a refund by visiting www.tylenol.com or contacting McNeil at 888-222-6036 Monday through Friday 8 a.m. to 8 p.m. ET and Saturday and Sunday 9 a.m. to 5 p.m. ET. Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information.
The lot numbers and UPC code for the recalled products are:
BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00
Injuries that could be related to the use of the Infants Tylenol can be reported to U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 800-FDA-0178.