McNeil Consumer Healthcare is voluntarily recalling three lots, at the wholesale and retail levels, of approximately 200,000 bottles of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fl oz that have been distributed nationwide in the United States.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA) and McNeil is asking retailers to remove the affected lots from store shelves and asking patients and consumers to stop using and dispose of any product they may have that is included in this recall.
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 supplier 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 MOTRIN® Infants’ Drops Dye-Free Berry Flavor 1 fl oz and Children’s or Adult MOTRIN® products are not included in this recall.
If you have any questions or concerns, or would like to inquire about a refund, you can call the McNeil Consumer Care Center at 1-877-414-7709. Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.motrin.com for additional information.