In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States.
This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil's Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.
Children's BENADRYL® Allergy FASTMELT® Tablets, Cherry Flavor
NDC Code: 50580-347-18
UPC Code: 300450180186
Children's BENADRYL® Allergy FASTMELT® Tablets, Grape Flavor
NDC Code: 50580-348-18
UPC Code: 300450190185
unior Strength MOTRIN® CAPLETS, 24 count
NDC Code: 50580-498-24
UPC Code: 300450498243
Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. - 8 p.m. ET and Saturday - Sunday, 9 a.m. - 5 p.m. Eastern Time.)