The makers of Motrin Infant Drops, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (McNeil), has voluntarily recalled three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles from wholesalers and retail stores in the United States. McNeil is asking consumers to stop using and dispose of any product they may have that is included in this recall.
Product Lot # UPC Code Case UPC Code
Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz bottles
NDC 50580-100-18 DCB3T01
DDB4R01
DDB4S01 300450524157 30300450524158
After releasing these three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot during manufacturing. This lot was not released to the market. It was determined that the particles originated in a shipment from a third-party supplier of ibuprofen, the active ingredient in Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz. Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient. McNeil has worked with the third-party to ensure that corrective measures are currently in place and are effective. The potential for adverse medical events related to the reason for this recall is not likely. Concentrated Infants’ MOTRIN® Drops Dye-Free Berry Flavor 1 fl oz is not included in this recall. Children’s and Adult MOTRIN® products also are not included in the recall.
Infant’s Motrin Recall
September 9, 2013