Three lots, or approximately 200,000 bottles, of Concentrated Motrin Infants’ Drops are being recalled because small bits of plastic may be floating in the bottles. The recall affects the Original Berry Flavored ½ fl oz bottles distributed in the United States.
After releasing the three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor ½ fl oz into the market, tiny plastic particles measuring about 1 mm – about the size of a poppy seed – were seen in a different product lot during manufacturing. This lot was not released.
However, it was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in Concentrated Infants’ Motrin. As a result, out of an abundance of caution, McNeil Consumer Healthcare is recalling the three lots released to the market made with the same batch of active ingredient.
Motrin Drops Dye-Free Berry Flavor 1 fl oz is not involved in the recall, nor are any Children’s or Adult Motrin products.
McNeil Consumer Healthcare is asking retailers to remove the affected lots from store shelves. Consumers are advised to stop using and dispose of any infant drops affected by this recall.
Health care professionals and consumers are encouraged to report any side effects related to this recall to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.