March 20, 2026
The Federal Drug Regulatory Authority (FDA) has issued a major recall of children’s ibuprofen over potential contamination of nearly 90,000 bottles.
According to the FDA, a widely used children’s pain reliever is being recalled from shelves across the U.S. after reports emerge of a potential contamination, triggering a nationwide recall.
Detailing the stats, the agency said 89,592 bottles of liquid children’s ibuprofen are contaminated, as mentioned in FDA’s enforcement report.
Strides Pharma, a company that manufactures the product, issued the recall after receiving complaints that highlighted a “gel-like mass and black particles” inside the medication.
The FDA has classified the recall as Class II, a category that describes when a product poses health issues that can be reversed with medical treatment.
The recall is meant to pull out products from store shelves rather than homes, unless any further action is issued by the FDA.
The recalled product was manufactured by Strides Pharma for Taro Pharmaceuticals USA and marketed across the U.S.
Ibuprofen contains 100-milligrams per 5-milliliter oral suspension sold in 4-fluid-ounce bottles.
The FDA provided the lot numbers of the recalled product which are 7261973A and 7261974A, with an expiry date of January 31, 2027.
Health experts have advised parents and caretakers to avoid administering the recalled product and urged those whose children have consumed the product before the FDA recall to consult a pediatrician.