FDA Recalls 90,000 Children's Ibuprofen Bottles Nationwide After Consumers Report Black Particles, Gel Mass

The cause of contamination and the number of complaints remain undisclosed, with no images or details provided by the FDA. (Credit: DailyMed)

The US Food and Drug Administration (FDA) has recalled 89,592 bottles of children's ibuprofen sold nationwide after consumers reported finding black particles and a gel-like mass inside the liquid medication, raising alarm among parents who rely on the drug for their children's fevers and pain relief.

The voluntary recall was initiated on 2 March by Strides Pharma Inc., an India-headquartered pharmaceutical manufacturer with US operations in Bridgewater, New Jersey. But the FDA didn't formally classify the recall until 16 March, a two-week gap that left parents without a clear picture of the risk level during a critical window.