US FDA recalls nearly 90,000 bottles of India-made children's Ibuprofen oral medication

The FDA notice states that the recall was launched earlier this month after customers reported "a gel-like mass and black particles in the product."

The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (Photo | AP, FILE)

WASHINGTON: Nearly 90,000 bottles of a children's pain reliever have been recalled due to reports of black specs and other contaminants, according to federal regulators.

The Food and Drug Administration posted an online notice about the recall of Taro Pharmaceuticals' Children's Ibuprofen Oral Suspension. The company's website states that the product comes in a berry-flavored solution and is recommended for children ages 2 to 11.

The FDA notice states that the recall was launched earlier this month after customers reported "a gel-like mass and black particles in the product." Agency regulators categorized the action as one in which the risk of serious injury or health consequences to consumers is "remote."

The medication was manufactured in India by Strides Pharma Inc., which produces generic and over-the-counter medicines for firms in the US and many other countries.

Strides initiated the recall, according to the FDA notice.

Neither Strides nor Taro Pharmaceuticals immediately responded to requests for comment Friday morning.