Recall of Children’s Ibuprofen Due to Contaminants

A recall has been issued for a children’s painkiller sold in the U.S. after reports emerged of foreign substances in the product, federal regulators have announced.

Approximately 90,000 bottles of pediatric ibuprofen oral suspension are affected. Consumers reported discovering “gel-like lumps and black particles” inside the bottles, as noted in an enforcement report.

This liquid ibuprofen was produced in India for Tullow Pharmaceuticals USA and is distributed nationwide.

The recall began on March 2 by Stride Pharma, based in New Jersey, and is still ongoing.

The affected medication is taken in doses of 100 milligrams per teaspoon and is packaged in 4-ounce bottles. Specifically, the recalled lots are 7261973A and 7261974A, with an expiration date of January 31, 2027.

Federal agencies have categorized the recall as a Class II, suggesting the product may lead to temporary or reversible health issues, but the likelihood of serious injury or death remains low.

Stride Pharma voluntarily initiated the recall after receiving complaints regarding foreign objects found in the bottles. The FDA report hasn’t specified the number of complaints nor indicated any injuries associated with the product.

Officials from Stride Pharma and Taro Pharmaceuticals USA have been contacted for further information.

Ibuprofen is a commonly used pain reliever that addresses various symptoms, including fever and inflammation, by inhibiting certain chemicals in the body. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).

In the U.S., ibuprofen is available both over-the-counter and by prescription, often recognized by brand names like Advil and Motrin, in addition to generic options.

The drug is available in various formats, including tablets, capsules, and liquid formulations specifically designed for children.

Typically, it is used to alleviate mild to moderate pain, such as headaches and menstrual cramps, while also being effective in reducing fever.

For chronic conditions like arthritis, higher doses of prescription strength ibuprofen are utilized to manage inflammation, stiffness, and joint pain.